Court filing
Exhibit 13: WHO Essential Medicines List (Ivermectin) — Apter v. HHS (S.D. Tex.)
Filed August 8, 2022 in Apter v. Department of Health and Human Services; one of 66 filings from this case.
Record facts
| Court | U.S. District Court for the Southern District of Texas (Galveston Division) |
|---|---|
| Filed | 2022-08-08 |
U.S. District Court for the Southern District of Texas (Galveston Division) · No. 3:22-cv-00184 · Doc. 12-13 · 2022-08-08 · Docket on CourtListener
Full text
Exhibit 13 Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 1 of 67 Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 2 of 67 WHO/MHP/HPS/EML/2021.02 © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation. World Health Organization Model List of Essential Medicines – 22nd List, 2021. Geneva: World Health Organization; 2021 (WHO/MHP/HPS/EML/2021.02). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the policies of WHO. The recommendations contained in this publication are based on the advice of independent experts, who have considered the best available evidence, a risk–benefit analysis and other factors, as appropriate. This publication may include recommendations on the use of medicinal products for an indication, in a dosage form, dose regimen, population or other use parameters that are not included in the approved labelling. Relevant stakeholders should familiarize themselves with applicable national legal and ethical requirements. WHO does not accept any liability for the procurement, distribution and/or administration of any product for any use. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 3 of 67 WHO Model List of Essential Medicines – 22nd List (2021) Explanatory notes The core list presents a list of minimum medicine needs for a basic health-care system, listing the most efficacious, safe and cost–effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment. Where the [c] symbol is placed next to an individual medicine or strength of medicine on the core list it signifies that there is a specific indication for restricting its use to children. The complementary list presents essential medicines for priority diseases, for which specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training are needed. In case of doubt medicines may also be listed as complementary on the basis of consistent higher costs or less attractive cost-effectiveness in a variety of settings. Where the [c] symbol is placed next to an individual medicine or strength of medicine on the complementary list it signifies that the medicine(s) require(s) specialist diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training for their use in children. The square box symbol () is intended to indicate therapeutic alternatives to the listed medicine that may be considered for selection in national essential medicines lists. Alternatives may be individual medicines, or multiple medicines within a pharmacological class or chemical subgroup, defined at the 4th level of the Anatomical Therapeutic Chemical (ATC) classification, which have similar clinical effectiveness and safety. The listed medicine should be the example of the class or subgroup for which there is the best evidence for effectiveness and safety. In some cases, this may be the first medicine that is licensed for marketing; in other instances, subsequently licensed compounds may be safer or more effective. Where there is no difference in terms of efficacy and safety data, the listed medicine should be the one that is generally available at the lowest price, based on international drug price information sources. Not all square box listings are applicable to medicine selection for children. A square box is not used to indicate alternative generic brands of the same small molecule medicines, nor alternative biosimilars of biological medicines. However, the selection and use of quality-assured generics and biosimilars of essential medicines at country level is recommended. National lists should not use a similar symbol and should be specific in their final selection, which would depend on local availability and price. The a symbol indicates that there is an age or weight restriction on use of the medicine; details for each medicine can be found in Table 1.1. The presence of an entry on the Essential Medicines List carries no assurance as to pharmaceutical quality. It is the responsibility of the relevant national or regional drug regulatory authority to ensure that each product is of appropriate pharmaceutical quality (including stability) and that, when relevant, different products are interchangeable. For recommendations and advice concerning all aspects of the quality assurance of medicines see the WHO website https://www.who.int/teams/health-product-and-policy-standards/standards-and- specifications/norms-and-standards-for-pharmaceuticals/guidelines/quality-assurance Medicines and dosage forms are listed in alphabetical order within each section and the order of listing does not imply preference for one form over another. Standard treatment guidelines should be consulted for information on appropriate dosage forms. The main terms used for dosage forms in the Essential Medicines List can be found in Table 1.2. Definitions of many of these terms and pharmaceutical quality requirements applicable to the different categories are published in the current edition of The International Pharmacopoeia. https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/norms-and- standards-for-pharmaceuticals/pharmacopoeia. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 4 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 1 1. ANAESTHETICS, PREOPERATIVE MEDICINES AND MEDICAL GASES 1.1 General anaesthetics and oxygen 1.1.1 Inhalational medicines halothane Inhalation. isoflurane Inhalation. nitrous oxide Inhalation. oxygen Inhalation (medical gas). 1.1.2 Injectable medicines ketamine Injection: 50 mg/mL (as hydrochloride) in 10 mL vial. propofol Therapeutic alternatives: - thiopental Injection: 10 mg/mL; 20 mg/mL. 1.2 Local anaesthetics bupivacaine Therapeutic alternatives to be reviewed (2023) Injection: 0.25%; 0.5% (hydrochloride) in vial. Injection for spinal anaesthesia: 0.5% (hydrochloride) in 4 mL ampoule to be mixed with 7.5% glucose solution. lidocaine Therapeutic alternatives to be reviewed (2023) Injection: 1%; 2% (hydrochloride) in vial. Injection for spinal anaesthesia: 5% (hydrochloride) in 2 mL ampoule to be mixed with 7.5% glucose solution. Topical forms: 2% to 4% (hydrochloride). lidocaine + epinephrine (adrenaline) Dental cartridge: 2% (hydrochloride) + epinephrine 1:80 000. Injection: 1%; 2% (hydrochloride or sulfate) + epinephrine 1:200 000 in vial. Complementary List ephedrine Injection: 30 mg/mL (hydrochloride) in 1 mL ampoule. (For use in spinal anaesthesia during delivery, to prevent hypotension). 1.3 Preoperative medication and sedation for short-term procedures atropine Injection: 1 mg (sulfate) in 1 mL ampoule. midazolam Therapeutic alternatives to be reviewed (2023) Injection: 1 mg/mL. Oral liquid: 2 mg/mL [c]. Tablet: 7.5 mg; 15 mg. morphine Injection: 10 mg (sulfate or hydrochloride) in 1 mL ampoule. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 5 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 2 1.4 Medical gases oxygen* Inhalation For use in the management of hypoxaemia. *No more than 30% oxygen should be used to initiate resuscitation of neonates less than or equal to 32 weeks of gestation. 2. MEDICINES FOR PAIN AND PALLIATIVE CARE 2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs) acetylsalicylic acid Suppository: 50 mg to 150 mg. Tablet: 100 mg to 500 mg. ibuprofen a Oral liquid: 200 mg/5 mL. Tablet: 200 mg; 400 mg; 600 mg. a Not in children less than 3 months. paracetamol* Oral liquid: 120 mg/5 mL; 125 mg/5 mL. Suppository: 100 mg. Tablet: 100 mg to 500 mg. *Not recommended for anti-inflammatory use due to lack of proven benefit to that effect. 2.2 Opioid analgesics codeine Tablet: 30 mg (phosphate). fentanyl* Transdermal patch: 12 micrograms/hr; 25 micrograms/hr; 50 micrograms/hr; 75 micrograms/hr; 100 micrograms/hr *For the management of cancer pain morphine Therapeutic alternatives: - hydrormorphone - oxycodone Granules (slow release; to mix with water): 20 mg to 200 mg (morphine sulfate). Injection: 10 mg (morphine hydrochloride or morphine sulfate) in 1 mL ampoule. Oral liquid: Tablet (slow release): 10 mg to 200mg (morphine hydrochloride or morphine sulfate). Tablet (immediate release): 10 mg (morphine sulfate). Complementary list methadone* Tablet: 5 mg; 10 mg (hydrochloride) Oral liquid: 5 mg/5 mL; 10 mg/5 mL (hydrochloride) Concentrate for oral liquid: 5 mg/mL; 10 mg/mL (hydrochloride) *For the management of cancer pain. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 6 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 3 2.3 Medicines for other common symptoms in palliative care amitriptyline Tablet: 10 mg; 25 mg; 75 mg. cyclizine [c] Injection: 50 mg/mL. Tablet: 50 mg. dexamethasone Injection: 4 mg/mL (as disodium phosphate salt) in 1 mL ampoule. Oral liquid: 2 mg/5 mL. Tablet: 2 mg [c]; 4 mg. diazepam Injection: 5 mg/mL. Oral liquid: 2 mg/5 mL. Rectal solution: 2.5 mg; 5 mg; 10 mg. Tablet: 5 mg; 10 mg. docusate sodium Capsule: 100 mg. Oral liquid: 50 mg/5 mL. fluoxetine a Solid oral dosage form: 20 mg (as hydrochloride). a > 8 years. haloperidol Injection: 5 mg in 1 mL ampoule. Oral liquid: 2 mg/mL. Solid oral dosage form: 0.5 mg; 2mg; 5 mg. hyoscine butylbromide Injection: 20 mg/mL. hyoscine hydrobromide [c] Injection: 400 micrograms/mL; 600 micrograms/mL. Transdermal patches: 1 mg/72 hours. lactulose [c] Oral liquid: 3.1 to 3.7 g/5 mL. loperamide Solid oral dosage form: 2 mg. metoclopramide Injection: 5 mg/mL (hydrochloride) in 2 mL ampoule. Oral liquid: 5 mg/5 mL. Solid oral form: 10 mg (hydrochloride). midazolam Injection: 1 mg/mL; 5 mg/mL. Oral liquid: 2mg/mL [c]. Solid oral dosage form: 7.5 mg; 15 mg. ondansetron a Therapeutic alternatives: - dolasetron - granisetron - palonosetron - tropisetron Injection: 2 mg base/mL in 2 mL ampoule (as hydrochloride). Oral liquid: 4 mg base/5 mL. Solid oral dosage form: Eq 4 mg base; Eq 8 mg base. a > 1 month. senna Oral liquid: 7.5 mg/5 mL. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 7 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 4 3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS dexamethasone Injection: 4 mg/mL (as disodium phosphate salt) in 1 mL ampoule. epinephrine (adrenaline) Injection: 1 mg/mL (as hydrochloride or hydrogen tartrate) in 1 mL ampoule. hydrocortisone Powder for injection: 100 mg (as sodium succinate) in vial. loratadine* Therapeutic alternatives: - cetirizine - fexofenadine Oral liquid: 1 mg/mL. Tablet: 10 mg. *There may be a role for sedating antihistamines for limited indications (EMLc). prednisolone Therapeutic alternatives: - prednisone Oral liquid: 5 mg/mL [c]. Tablet: 5 mg; 25 mg. 4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS 4.1 Non-specific charcoal, activated Powder. 4.2 Specific acetylcysteine Injection: 200 mg/mL in 10 mL ampoule. Oral liquid: 10% [c]; 20% [c]. atropine Injection: 1 mg (sulfate) in 1 mL ampoule. calcium gluconate Injection: 100 mg/mL in 10 mL ampoule. methylthioninium chloride (methylene blue) Injection: 10 mg/mL in 10 mL ampoule. naloxone Injection: 400 micrograms (hydrochloride) in 1 mL ampoule. penicillamine Solid oral dosage form: 250 mg. potassium ferric hexacyano-ferrate(II) -2H2O (Prussian blue) Powder for oral administration. sodium nitrite Injection: 30 mg/mL in 10 mL ampoule. sodium thiosulfate Injection: 250 mg/mL in 50 mL ampoule. Complementary List deferoxamine Powder for injection: 500 mg (mesilate) in vial. dimercaprol Injection in oil: 50 mg/mL in 2 mL ampoule. fomepizole Injection: 5 mg/mL (sulfate) in 20 mL ampoule or 1 g/mL (base) in 1.5 mL ampoule. sodium calcium edetate Injection: 200 mg/mL in 5 mL ampoule. succimer Solid oral dosage form: 100 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 8 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 5 5. ANTICONVULSANTS/ANTIEPILEPTICS carbamazepine Oral liquid: 100 mg/5 mL. Tablet (chewable): 100 mg; 200 mg. Tablet (scored): 100 mg; 200 mg. diazepam Gel or rectal solution: 5 mg/mL in 0.5 mL; 2 mL; 4 mL tubes. lamotrigine* Tablet: 25 mg; 50 mg; 100 mg; 200 mg. Tablet (chewable, dispersible): 2 mg; 5 mg; 25 mg; 50 mg; 100 mg; 200 mg. *For use as adjunctive therapy for treatment-resistant partial or generalized seizures. lorazepam Therapeutic alternatives: - diazepam (injection) - midazolam (injection) Injection: 2 mg/mL in 1 mL ampoule; 4 mg/mL in 1 mL ampoule. magnesium sulfate* Injection: 0.5 g/mL in 2 mL ampoule (equivalent to 1 g in 2 mL; 50% weight/volume); 0.5 g/mL in 10 mL ampoule (equivalent to 5 g in 10 mL; 50% weight/volume). *For use in eclampsia and severe pre-eclampsia and not for other convulsant disorders. midazolam Solution for oromucosal administration: 5 mg/mL; 10 mg/mL. Ampoule*: 1 mg/mL; 10 mg/mL. *For buccal administration when solution for oromucosal administration is not available. phenobarbital Injection: 200 mg/mL (sodium). Oral liquid: 15 mg/5 mL. Tablet: 15 mg to 100 mg. phenytoin Injection: 50 mg/mL (sodium) in 5 mL vial. Oral liquid: 25 mg to 30 mg/5 mL.* Solid oral dosage form: 25 mg; 50 mg; 100 mg (sodium). Tablet (chewable): 50 mg. *The presence of both 25 mg/5 mL and 30 mg/5 mL strengths on the same market would cause confusion in prescribing and dispensing and should be avoided. valproic acid (sodium valproate)* *Avoid use in pregnancy and in women and girls of child- bearing potential, unless alternative treatments are ineffective or not tolerated because of the high risk of birth defects and developmental disorders in children exposed to valproate in the womb. Oral liquid: 200 mg/5 mL. Tablet (crushable): 100 mg. Tablet (enteric-coated): 200 mg; 500 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 9 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 6 Complementary List ethosuximide Capsule: 250 mg. Oral liquid: 250 mg/5 mL. valproic acid (sodium valproate)* *Avoid use in pregnancy and in women and girls of child-bearing potential, unless alternative treatments are ineffective or not tolerated because of the high risk of birth defects and developmental disorders in children exposed to valproate in the womb. Injection: 100 mg/mL in 4 mL ampoule; 100 mg/mL in 10 mL ampoule. 6. ANTI-INFECTIVE MEDICINES 6.1 Anthelminthics 6.1.1 Intestinal anthelminthics albendazole Tablet (chewable): 400 mg. ivermectin Tablet (scored): 3 mg. levamisole Tablet: 50 mg; 150 mg (as hydrochloride). mebendazole Tablet (chewable): 100 mg; 500 mg. niclosamide Tablet (chewable): 500 mg. praziquantel Tablet: 150 mg; 600 mg. pyrantel Oral liquid: 50 mg/mL (as embonate or pamoate). Tablet (chewable): 250 mg (as embonate or pamoate). 6.1.2 Antifilarials albendazole Tablet (chewable): 400 mg. diethylcarbamazine Tablet: 50 mg; 100 mg (dihydrogen citrate). ivermectin Tablet (scored): 3 mg. 6.1.3 Antischistosomals and other antitrematode medicines praziquantel Tablet: 600 mg. triclabendazole Tablet: 250 mg. Complementary List oxamniquine* Capsule: 250 mg. Oral liquid: 250 mg/5 mL. *For use when praziquantel treatment fails. 6.1.4 Cysticidal medicines Complementary List albendazole Tablet (chewable): 400 mg. mebendazole Tablet (chewable): 500 mg. praziquantel Tablet: 500 mg; 600 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 10 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 7 6.2 Antibacterials To assist in the development of tools for antibiotic stewardship at local, national and global levels and to reduce antimicrobial resistance, the Access, Watch, Reserve (AWaRe) classification of antibiotics was developed – where antibiotics are classified into different groups to emphasize the importance of their appropriate use. ACCESS GROUP ANTIBIOTICS This group includes antibiotics that have activity against a wide range of commonly encountered susceptible pathogens while also showing lower resistance potential than antibiotics in the other groups. Selected Access group antibiotics are recommended as essential first or second choice empiric treatment options for infectious syndromes reviewed by the EML Expert Committee and are listed as individual medicines on the Model Lists to improve access and promote appropriate use. They are essential antibiotics that should be widely available, affordable and quality assured. WATCH GROUP ANTIBIOTICS This group includes antibiotic classes that have higher resistance potential and includes most of the highest priority agents among the Critically Important Antimicrobials for Human Medicine and/or antibiotics that are at relatively high risk of selection of bacterial resistance. These medicines should be prioritized as key targets of stewardship programs and monitoring. Selected Watch group antibiotics are recommended as essential first or second choice empiric treatment options for a limited number of specific infectious syndromes and are listed as individual medicines on the Model Lists. RESERVE GROUP ANTIBIOTICS This group includes antibiotics and antibiotic classes that should be reserved for treatment of confirmed or suspected infections due to multi-drug-resistant organisms. Reserve group antibiotics should be treated as “last resort” options. Selected Reserve group antibiotics are listed as individual medicines on the Model Lists when they have a favourable risk- benefit profile and proven activity against “Critical Priority” or “High Priority” pathogens identified by the WHO Priority Pathogens List, notably carbapenem resistant Enterobacteriaceae. These antibiotics should be accessible, but their use should be tailored to highly specific patients and settings, when all alternatives have failed or are not suitable. These medicines could be protected and prioritized as key targets of national and international stewardship programs involving monitoring and utilization reporting, to preserve their effectiveness. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 11 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 8 6.2.1 Access group antibiotics amikacin Injection: 250 mg/mL (as sulfate) in 2 mL vial. FIRST CHOICE − High-risk febrile neutropenia − Pyelonephritis or prostatitis (severe) SECOND CHOICE − Sepsis in neonates and children [c] amoxicillin Powder for injection: 250 mg; 500 mg; 1 g (as sodium) in vial. Powder for oral liquid: 125 mg/5 mL; 250 mg/5 mL (as trihydrate) [c]. Solid oral dosage form: 250 mg; 500 mg; 1g (as trihydrate). FIRST CHOICE − Community acquired pneumonia (mild to moderate) − Community acquired pneumonia (severe) [c] − Complicated severe acute malnutrition [c] − Exacerbations of COPD − Otitis media − Pharyngitis − Progressive apical dental abscess − Sepsis in neonates and children [c] − Sinusitis − Uncomplicated severe acute malnutrition [c] SECOND CHOICE − Acute bacterial meningitis amoxicillin + clavulanic acid Powder for injection: 500 mg (as sodium) + 100 mg (as potassium salt); 1000 mg (as sodium) + 200 mg (as potassium salt) in vial. Powder for oral liquid: 125 mg (as trihydrate)+ 31.25 mg (as potassium salt)/5 mL; 250 mg (as trihydrate) + 62.5 mg (as potassium salt)/5mL [c]. Tablet: 500 mg (as trihydrate) + 125 mg (as potassium salt); 875 mg (as trihydrate) + 125 mg (as potassium salt). FIRST CHOICE − Community acquired pneumonia (severe) [c] − Complicated intraabdominal infections (mild to moderate) − Exacerbations of COPD − Hospital acquired pneumonia − Low-risk febrile neutropenia − Lower urinary tract infections − Sinusitis − Skin and soft tissue infections SECOND CHOICE − Bone and joint infections − Community-acquired pneumonia (mild to moderate) − Community acquired pneumonia (severe) − Otitis media − Surgical prophylaxis Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 12 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 9 ampicillin Powder for injection: 500 mg; 1 g (as sodium) in vial. FIRST CHOICE − Community acquired pneumonia (severe) [c] − Complicated intraabdominal infections [c] − Complicated severe acute malnutrition [c] − Sepsis in neonates and children [c] SECOND CHOICE − Acute bacterial meningitis benzathine benzylpenicillin Powder for injection: 1.2 million IU (≈ 900 mg) in vial [c]; 2.4 million IU (≈ 1.8 g) in vial. FIRST CHOICE − Syphilis SECOND CHOICE benzylpenicillin Powder for injection: 600 mg (= 1 million IU); 3 g (= 5 million IU) (sodium or potassium salt) in vial. FIRST CHOICE − Community acquired pneumonia (severe) [c] − Complicated severe acute malnutrition [c] − Sepsis in neonates and children [c] − Syphilis SECOND CHOICE − Acute bacterial meningitis [c] cefalexin Powder for oral liquid: 125 mg/5 mL; 250 mg/5 mL (anhydrous). Solid oral dosage form: 250 mg; 500 mg (as monohydrate). FIRST CHOICE − Skin and soft tissue infections SECOND CHOICE − Exacerbations of COPD − Pharyngitis cefazolin a Powder for injection: 1 g (as sodium salt) in vial. a > 1 month. FIRST CHOICE − Surgical prophylaxis SECOND CHOICE − Bone and joint infections chloramphenicol Capsule: 250 mg. Oily suspension for injection*: 0.5 g/mL (as sodium succinate) in 2 mL ampoule. *Only for the presumptive treatment of epidemic meningitis in children older than 2 years and in adults. Oral liquid: 150 mg/5 mL (as palmitate). Powder for injection: 1 g (sodium succinate) in vial. FIRST CHOICE SECOND CHOICE − Acute bacterial meningitis Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 13 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 10 clindamycin Capsule: 150 mg (as hydrochloride). Injection: 150 mg/mL (as phosphate); 600 mg/4 mL (as phosphate); 900 mg/6 mL (as phosphate). Oral liquid: 75 mg/5 mL (as palmitate) [c]. FIRST CHOICE − Necrotizing fasciitis SECOND CHOICE − Bone and joint infections cloxacillin* Therapeutic alternatives: - 4th level ATC chemical subgroup (J01CF Beta-lactamase resistant penicillins) Capsule: 500 mg; 1 g (as sodium). Powder for injection: 500 mg (as sodium) in vial. Powder for oral liquid: 125 mg/5 mL (as sodium). *cloxacillin, dicloxacillin and flucloxacillin are preferred for oral administration due to better bioavailability. FIRST CHOICE − Bone and joint infections − Skin and soft tissue infections SECOND CHOICE − Sepsis in neonates and children [c] doxycycline a Oral liquid: 25 mg/5 mL [c]; 50 mg/5 mL (anhydrous) [c]. Powder for injection: 100 mg in vial. Solid oral dosage form: 50 mg [c]; 100 mg (as hyclate). a Use in children <8 years only for life-threatening infections when no alternative exists. FIRST CHOICE − Cholera − Sexually transmitted infection due to Chlamydia trachomatis SECOND CHOICE − Cholera [c] − Community acquired pneumonia (mild to moderate) − Exacerbations of COPD gentamicin Injection: 10 mg/mL (as sulfate); 40 mg/mL (as sulfate) in 2 mL vial. FIRST CHOICE − Acute bacterial meningitis in neonates [c] − Community acquired pneumonia (severe) [c] − Complicated intraabdominal infections [c] − Complicated severe acute malnutrition [c] − Sepsis in neonates and children [c] SECOND CHOICE − Gonorrhoea − Surgical prophylaxis Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 14 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 11 metronidazole Injection: 500 mg in 100 mL vial. Oral liquid: 200 mg/5 mL (as benzoate). Suppository: 500 mg; 1 g. Tablet: 200 mg to 500 mg. FIRST CHOICE − C. difficile infection − Complicated intraabdominal infections (mild to moderate) − Complicated intrabdominal infections (severe) − Necrotizing fasciitis − Surgical prophylaxis − Trichomoniasis SECOND CHOICE − Complicated intraabdominal infections (mild to moderate) nitrofurantoin Oral liquid: 25 mg/5 mL [c]. Tablet: 100 mg. FIRST CHOICE − Lower urinary tract infections SECOND CHOICE phenoxymethylpenicillin Powder for oral liquid: 250 mg/5 mL (as potassium). Tablet: 250 mg; 500 mg (as potassium). FIRST CHOICE − Community acquired pneumonia (mild to moderate) − Pharyngitis − Progressive apical dental abscess SECOND CHOICE procaine benzylpenicillin* Powder for injection: 1 g (=1 million IU); 3 g (=3 million IU) in vial. *Procaine benzylpenicillin is not recommended as first-line treatment for neonatal sepsis except in settings with high neonatal mortality, when given by trained health workers in cases where hospital care is not achievable. FIRST CHOICE − Syphilis (congenital) [c] SECOND CHOICE − Syphilis spectinomycin Powder for injection: 2 g (as hydrochloride) in vial. FIRST CHOICE SECOND CHOICE − Gonorrhoea sulfamethoxazole + trimethoprim Injection: 80 mg + 16 mg/mL in 5 mL ampoule; 80 mg + 16 mg/mL in 10 mL ampoule. Oral liquid: 200 mg + 40 mg/5 mL. Tablet: 100 mg + 20 mg; 400 mg + 80 mg; 800 mg + 160 mg. FIRST CHOICE − Lower urinary tract infections SECOND CHOICE − Acute invasive diarrhoea / bacterial dysentery Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 15 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 12 trimethoprim Tablet: 100 mg; 200 mg. Oral liquid: 50 mg/5 mL [c]. FIRST CHOICE − Lower urinary tract infections SECOND CHOICE 6.2.2 Watch group antibiotics azithromycin Capsule: 250 mg; 500 mg (anhydrous). Oral liquid: 200 mg/5 mL. FIRST CHOICE − Cholera [c] − Enteric fever − Gonorrhoea − Sexually transmitted infection due to Chlamydia trachomatis − Trachoma − Yaws SECOND CHOICE − Acute invasive bacterial diarrhoea / dysentery − Gonorrhoea cefixime Powder for oral liquid: 100 mg/5 mL [c]. Solid oral dosage form: 200 mg; 400 mg (as trihydrate). FIRST CHOICE SECOND CHOICE − Acute invasive bacterial diarrhoea / dysentery − Gonorrhoea cefotaxime* Powder for injection: 250 mg (as sodium) in vial. *3rd generation cephalosporin of choice for use in hospitalized neonates. FIRST CHOICE − Acute bacterial meningitis − Community acquired pneumonia (severe) − Complicated intraabdominal infections (mild to moderate) − Complicated intraabdominal infections (severe) − Hospital acquired pneumonia − Pyelonephritis or prostatitis (severe) SECOND CHOICE − Bone and joint infections − Pyelonephritis or prostatitis (mild to moderate) − Sepsis in neonates and children [c] Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 16 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 13 ceftriaxone* a Powder for injection: 250 mg; 1 g; 2 g (as sodium) in vial. *Do not administer with calcium and avoid in infants with hyperbilirubinaemia. a > 41 weeks corrected gestational age. FIRST CHOICE − Acute bacterial meningitis − Community acquired pneumonia (severe) − Complicated intraabdominal infections (mild to moderate) − Complicated intrabdominal infections (severe) − Endophthalmitis − Enteric fever − Gonorrhoea − Hospital acquired pneumonia − Necrotizing fasciitis − Pyelonephritis or prostatitis (severe) SECOND CHOICE − Acute invasive bacterial diarrhoea / dysentery − Bone and joint infections − Pyelonephritis or prostatitis (mild to moderate) − Sepsis in neonates and children [c] cefuroxime Powder for injection: 250 mg; 750 mg; 1.5 g (as sodium) in vial. FIRST CHOICE SECOND CHOICE − Surgical prophylaxis ciprofloxacin Oral liquid: 250 mg/5 mL (anhydrous) [c]. Solution for IV infusion: 2 mg/mL (as hyclate) [c]. Solid oral dosage form: 250 mg; 500 mg (as hydrochloride). FIRST CHOICE − Acute invasive bacterial diarrhoea / dysentery − Enteric fever − Low-risk febrile neutropenia − Pyelonephritis or prostatitis (mild to moderate) SECOND CHOICE − Cholera − Complicated intraabdominal infections (mild to moderate) clarithromycin† Therapeutic alternatives: - erythromycin* *as second choice treatment for pharyngitis in children (EMLc only) Powder for oral liquid: 125 mg/5 mL; 250 mg/5 mL. Powder for injection: 500 mg in vial. Solid oral dosage form: 500 mg. †clarithromycin is also listed for use in combination regimens for eradication of H. pylori in adults. FIRST CHOICE Community acquired pneumonia (severe) SECOND CHOICE − Pharyngitis Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 17 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 14 piperacillin + tazobactam Powder for injection: 2 g (as sodium) + 250 mg (as sodium); 4 g (as sodium) + 500 mg (as sodium) in vial. FIRST CHOICE − Complicated intraabdominal infections (severe) − High-risk febrile neutropenia − Hospital acquired pneumonia − Necrotizing fasciitis SECOND CHOICE vancomycin Capsule: 125 mg; 250 mg (as hydrochloride). FIRST CHOICE SECOND CHOICE − C. difficile infection Complementary List ceftazidime Powder for injection: 250 mg; 1 g (as pentahydrate) in vial. FIRST CHOICE − Endophthalmitis SECOND CHOICE meropenem* a Therapeutic alternatives*: - imipenem + cilastatin *complicated intraabdominal infections and high-risk febrile neutropenia only. Meropenem is the preferred choice for acute bacterial meningitis in neonates. Powder for injection: 500 mg (as trihydrate); 1 g (as trihydrate) in vial. a > 3 months. FIRST CHOICE SECOND CHOICE − Acute bacterial meningitis in neonates [c] − Complicated intraabdominal infections (severe) − High-risk febrile neutropenia vancomycin Powder for injection: 250 mg; 500 mg; 1 g (as hydrochloride) in vial. FIRST CHOICE − Endophthalmitis − Necrotizing fasciitis SECOND CHOICE − High-risk febrile neutropenia 6.2.3 Reserve group antibiotics Complementary List cefiderocol Powder for injection: 1 g (as sulfate toxylate) in vial. ceftazidime + avibactam Powder for injection: 2 g + 0.5 g in vial. colistin Powder for injection: 1 million IU (as colistemethate sodium) in vial. fosfomycin Powder for injection: 2 g; 4 g (as sodium) in vial. linezolid Injection for intravenous administration: 2 mg/mL in 300 mL bag. Powder for oral liquid: 100 mg/5 mL. Tablet: 400 mg; 600 mg. meropenem + vaborbactam Powder for injection: 1 g (as trihydrate) + 1 g in vial. plazomicin Injection: 500 mg/10 mL. polymyxin B Powder for injection: 500,000 IU in vial. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 18 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 15 6.2.4 Antileprosy medicines Medicines used in the treatment of leprosy should never be used except in combination. Combination therapy is essential to prevent the emergence of drug resistance. Colour-coded blister packs (MDT blister packs) containing standard two-medicine (paucibacillary leprosy) or three-medicine (multibacillary leprosy) combinations for adult and childhood leprosy should be used. MDT blister packs can be supplied free of charge through WHO. clofazimine Capsule: 50 mg; 100 mg. dapsone Tablet: 25 mg; 50 mg; 100 mg. rifampicin Solid oral dosage form: 150 mg; 300 mg. 6.2.5 Antituberculosis medicines WHO recommends and endorses the use of fixed-dose combinations and the development of appropriate new fixed-dose combinations, including modified dosage forms, non-refrigerated products and paediatric dosage forms of assured pharmaceutical quality. ethambutol Oral liquid: 25 mg/mL [c]. Tablet: 100 mg; 400 mg (hydrochloride). Tablet (dispersible): 100 mg [c] ethambutol + isoniazid + pyrazinamide + rifampicin Tablet: 275 mg + 75 mg + 400 mg + 150 mg. ethambutol + isoniazid + rifampicin Tablet: 275 mg + 75 mg + 150 mg. isoniazid Oral liquid: 50 mg/5 mL [c]. Tablet: 100 mg; 300 mg. Tablet (dispersible): 100 mg [c]. isoniazid + pyrazinamide + rifampicin Tablet (dispersible): 50 mg + 150 mg + 75 mg [c]. isoniazid + rifampicin Tablet: 75 mg + 150 mg; 150 mg + 300 mg. Tablet (dispersible): 50 mg + 75 mg [c]. isoniazid + rifapentine Tablet (scored): 300 mg + 300 mg. moxifloxacin Tablet: 400 mg. pyrazinamide Oral liquid: 30 mg/mL [c]. Tablet: 400 mg; 500 mg Tablet (dispersible): 150 mg. rifabutin Solid oral dosage form: 150 mg.* *For use only in patients with HIV receiving protease inhibitors. rifampicin Oral liquid: 20 mg/mL [c]. Solid oral dosage form: 150 mg; 300 mg. rifapentine Tablet: 150 mg; 300 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 19 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 16 Complementary List Medicines for the treatment of multidrug-resistant tuberculosis (MDR-TB) should be used in specialized centres adhering to WHO standards for TB control. amikacin Injection: 100 mg/2 mL (as sulfate) in 2 mL vial; 250 mg/mL (as sulfate) in 2 mL vial. amoxicillin + clavulanic acid* Powder for oral liquid: 250 mg (as trihydrate) + 62.5 mg (as potassium salt)/5mL [c]. Tablet: 500 mg (as trihydrate) + 125 mg (as potassium salt). *For use only in combination with meropenem or imipenem+cilastatin. bedaquiline a Tablet: 20 mg [c]; 100 mg. a ≥ 5 years clofazimine Solid oral dosage form: 50 mg; 100 mg. cycloserine Therapeutic alternatives: - terizidone Solid oral dosage form: 125 mg [c]; 250 mg. delamanid a Tablet (dispersible): 25 mg [c]. a ≥ 3 years Tablet: 50 mg. a ≥ 6 years ethionamide Therapeutic alternatives: - protionamide Tablet: 125 mg; 250 mg. Tablet (dispersible): 125 mg [c]. levofloxacin Tablet: 250mg; 500 mg; 750 mg. Tablet (dispersible): 100 mg [c]. linezolid Powder for oral liquid: 100 mg/5 mL. Tablet: 600 mg. Tablet (dispersible): 150 mg [c]. meropenem Therapeutic alternatives: - imipenem + cilastatin Powder for injection: 500 mg (as trihydrate); 1 g (as trihydrate) in vial. moxifloxacin Tablet: 400 mg. Tablet (dispersible): 100 mg [c]. p-aminosalicylic acid Granules: 4 g in sachet. streptomycin [c] Powder for injection: 1 g (as sulfate) in vial. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 20 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 17 6.3 Antifungal medicines amphotericin B Powder for injection: 50 mg (as sodium deoxycholate or liposomal complex) in vial. clotrimazole Vaginal cream: 1%; 10%. Vaginal tablet: 100 mg; 500 mg. fluconazole Capsule: 50 mg. Injection: 2 mg/mL in vial. Oral liquid: 50 mg/5 mL. flucytosine Capsule: 250 mg. Infusion: 2.5 g in 250 mL. griseofulvin Oral liquid: 125 mg/5 mL [c]. Solid oral dosage form: 125 mg; 250 mg. itraconazole* Capsule: 100 mg. Oral liquid: 10 mg/mL. *For treatment of chronic pulmonary aspergillosis, histoplasmosis, sporotrichosis, paracoccidiodomycosis, mycoses caused by T. marneffei and chromoblastomycosis; and prophylaxis of histoplasmosis and infections caused by T. marneffei in AIDS patients. nystatin Lozenge: 100 000 IU. Oral liquid: 50 mg/5 mL [c]; 100 000 IU/mL [c]. Pessary: 100 000 IU. Tablet: 100 000 IU; 500 000 IU. voriconazole* Tablet: 50 mg; 200 mg Powder for injection: 200 mg in vial Powder for oral liquid: 40 mg/mL *For treatment of chronic pulmonary aspergillosis and acute invasive aspergillosis. Complementary List micafungin Therapeutic alternatives: - anidulafungin - caspofungin Powder for injection: 50 mg (as sodium); 100 mg (as sodium) in vial. potassium iodide Saturated solution. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 21 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 18 6.4 Antiviral medicines 6.4.1 Antiherpes medicines aciclovir Therapeutic alternatives: - valaciclovir (oral) Oral liquid: 200 mg/5 mL [c]. Powder for injection: 250 mg (as sodium salt) in vial. Tablet: 200 mg. 6.4.2 Antiretrovirals Based on current evidence and experience of use, medicines in the following classes of antiretrovirals are included as essential medicines for treatment and prevention of HIV (prevention of mother-to-child transmission, pre-exposure prophylaxsis (where indicated) and post-exposure prophylaxis). WHO emphasizes the importance of using these products in accordance with global and national guidelines. WHO recommends and endorses the use of fixed-dose combinations and the development of appropriate new fixed-dose combinations, including modified dosage forms, non-refrigerated products and paediatric dosage forms of assured pharmaceutical quality. Scored tablets can be used in children and therefore can be considered for inclusion in the listing of tablets, provided that adequate quality products are available. 6.4.2.1 Nucleoside/Nucleotide reverse transcriptase inhibitors abacavir Tablet: 300 mg (as sulfate). lamivudine Oral liquid: 50 mg/5 mL [c]. Tablet: 150 mg. tenofovir disoproxil fumarate† Tablet: 300 mg (tenofovir disoproxil fumarate – equivalent to 245 mg tenofovir disoproxil). †also indicated for pre-exposure prophylaxis. zidovudine Capsule: 250 mg. Oral liquid: 50 mg/5 mL. Solution for IV infusion: 10 mg/mL in 20 mL vial. Tablet: 300 mg. 6.4.2.2 Non-nucleoside reverse transcriptase inhibitors efavirenz Tablet: 600 mg. nevirapine a Oral liquid: 50 mg/5 mL. Tablet: 50 mg (dispersible); 200 mg. a > 6 weeks 6.4.2.3 Protease inhibitors Selection of protease inhibitor(s) from the Model List will need to be determined by each country after consideration of international and national treatment guidelines and experience. Ritonavir is recommended for use in combination as a pharmacological booster, and not as an antiretroviral in its own right. All other protease inhibitors should be used in boosted forms (e.g. with ritonavir). atazanavir + ritonavir Tablet (heat stable): 300 mg (as sulfate) + 100 mg. darunavira Tablet: 75 mg; 400 mg; 600 mg; 800 mg a > 3 years lopinavir + ritonavir Solid oral dosage form: 40 mg + 10 mg [c]. Tablet (heat stable): 100 mg + 25 mg; 200 mg + 50 mg. ritonavir Tablet (heat stable): 25 mg; 100 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 22 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 19 6.4.2.4 Integrase inhibitors dolutegravir a Tablet (dispersible, scored): 10 mg [c]. a ≥ 4 weeks and ≥ 3 kg Tablet: 50 mg a ≥ 25 kg raltegravir* Granules for oral suspension: 100 mg in sachet. Tablet (chewable): 25 mg. Tablet: 400 mg. *For use in pregnant women and in second-line regimens in accordance with WHO treatemnt guidelines. 6.4.2.5 Fixed-dose combinations of antiretroviral medicines abacavir + lamivudine Tablet (dispersible, scored): 120 mg (as sulfate) + 60 mg. dolutegravir + lamivudine + tenofovir Tablet: 50 mg + 300 mg + 300 mg (tenofovir disoproxil fumarate – equivalent to 245 mg tenofovir disoproxil) efavirenz + emtricitabine + tenofovir Therapeutic alternatives: - lamivudine (for emtricitabine) Tablet: 600 mg + 200 mg + 300 mg (tenofovir disoproxil fumarate – equivalent to 245 mg tenofovir disoproxil). efavirenz + lamivudine + tenofovir Tablet: 400 mg + 300 mg + 300 mg (tenofovir disoproxil fumarate – equivalent to 245 mg tenofovir disoproxil) emtricitabine + tenofovir† Therapeutic alternatives: - lamivudine (for emtricitabine) Tablet: 200 mg + 300 mg (tenofovir disoproxil fumarate – equivalent to 245 mg tenofovir disoproxil). † combination also indicated for pre-exposure prophylaxis lamivudine + zidovudine Tablet: 30 mg + 60 mg [c]; 150 mg + 300 mg. 6.4.2.6 Medicines for prevention of HIV-related opportunistic infections isoniazid + pyridoxine + sulfamethoxazole + trimethoprim Tablet (scored): 300 mg + 25 mg + 800 mg + 160 mg 6.4.3 Other antivirals ribavirin* Injection for intravenous administration: 800 mg and 1 g in 10 mL phosphate buffer solution. Solid oral dosage form: 200 mg; 400 mg; 600 mg. *For the treatment of viral haemorrhagic fevers valganciclovir* Tablet: 450 mg. *For the treatment of cytomegalovirus retinitis (CMVr). Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 23 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 20 Complementary list oseltamivir* Capsule: 30 mg; 45 mg; 75 mg (as phosphate). *Severe illness due to confirmed or suspected influenza virus infection in critically ill hospitalized patients valganciclovir*[c] Powder for oral solution: 50 mg/mL Tablet: 450 mg. *For the treatment of cytomegalovirus retinitis (CMVr). 6.4.4 Antihepatitis medicines 6.4.4.1 Medicines for hepatitis B 6.4.4.1.1 Nucleoside/Nucleotide reverse transcriptase inhibitors entecavir Oral liquid: 0.05 mg/mL Tablet: 0.5 mg; 1 mg tenofovir disoproxil fumarate Tablet: 300 mg (tenofovir disoproxil fumarate – equivalent to 245 mg tenofovir disoproxil). 6.4.4.2 Medicines for hepatitis C Pangenotypic direct-acting antivirals should be considered as therapeutic alternatives for the purposes of selection and procurement at national level. 6.4.4.2.1 □ Pangenotypic direct-acting antiviral combinations daclatasvir* Tablet: 30 mg; 60 mg (as hydrochloride). *Pangenotypic when used in combination with sofosbuvir daclatasvir + sofosbuvir Tablet: 60 mg + 400 mg. glecaprevir + pibrentasvir Tablet: 100 mg + 40 mg. Granules: 50 mg + 20 mg in sachet [c]. sofosbuvir* Tablet: 200 mg; 400 mg. *Pangenotypic when used in combination with daclatasvir sofosbuvir + velpatasvir Tablet: 200 mg + 50 mg [c]; 400 mg + 100 mg. 6.4.4.2.2 Non-pangenotypic direct-acting antiviral combinations dasabuvir Tablet: 250 mg. ledipasvir + sofosbuvir Tablet: 90 mg + 400 mg. ombitasvir + paritaprevir + ritonavir Tablet: 12.5 mg + 75 mg + 50 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 24 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 21 6.4.4.2.3 Other antivirals for hepatitis C ribavirin* Injection for intravenous administration: 800 mg and 1 g in 10 mL phosphate buffer solution. Solid oral dosage form: 200 mg; 400 mg; 600 mg. *For the treatment of hepatitis C, in combination with direct acting anti-viral medicines Complementary list pegylated interferon alfa (2a or 2b) * Vial or pre-filled syringe: 180 micrograms (peginterferon alfa-2a). 80 micrograms, 100 micrograms (peginterferon alfa-2b). *To be used in combination with ribavirin. 6.5 Antiprotozoal medicines 6.5.1 Antiamoebic and antigiardiasis medicines diloxanide a Tablet: 500 mg (furoate). a > 25 kg. metronidazole Therapeutic alternatives: - tinidazole Injection: 500 mg in 100 mL vial. Oral liquid: 200 mg/5 mL (as benzoate). Tablet: 200 mg to 500 mg. 6.5.2 Antileishmaniasis medicines amphotericin B Powder for injection: 50 mg in vial (as sodium deoxycholate or liposomal complex). miltefosine Solid oral dosage form: 10 mg; 50 mg. paromomycin Solution for intramuscular injection: 750 mg of paromomycin base (as sulfate). sodium stibogluconate or meglumine antimoniate Injection: 100 mg/mL, 1 vial = 30 mL or 30%, equivalent to approximately 8.1% antimony (pentavalent) in 5 mL ampoule. 6.5.3 Antimalarial medicines 6.5.3.1 For curative treatment Medicines for the treatment of P. falciparum malaria cases should be used in combination. The list currently recommends combinations according to treatment guidelines. WHO recognizes that not all of the fixed dose combinations (FDCs) in the WHO treatment guidelines exist, and encourages their development and rigorous testing. WHO also encourages development and testing of rectal dosage formulations. amodiaquine* Tablet: 153 mg or 200 mg (as hydrochloride). *To be used in combination with artesunate 50 mg. artemether* Oily injection: 80 mg/mL in 1 mL ampoule. *For use in the management of severe malaria. artemether + lumefantrine* Tablet: 20 mg + 120 mg. Tablet (dispersible): 20 mg + 120 mg [c]. *Not recommended in the first trimester of pregnancy or in children below 5 kg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 25 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 22 artesunate* Injection: ampoules, containing 60 mg anhydrous artesunic acid with a separate ampoule of 5% sodium bicarbonate solution. For use in the management of severe malaria. Rectal dosage form: 50 mg [c]; 100 mg [c]; 200 mg capsules (for pre-referral treatment of severe malaria only; patients should be taken to an appropriate health facility for follow-up care) [c]. Tablet: 50 mg. *To be used in combination with either amodiaquine, mefloquine or sulfadoxine + pyrimethamine. artesunate + amodiaquine* Tablet: 25 mg + 67.5 mg; 50 mg + 135 mg; 100 mg + 270 mg. *Other combinations that deliver the target doses required such as 153 mg or 200 mg (as hydrochloride) with 50 mg artesunate can be alternatives. artesunate + mefloquine Tablet: 25 mg + 55 mg; 100 mg + 220 mg. artesunate + pyronaridine tetraphosphate a Granules: 20 mg + 60 mg [c]. Tablet: 60 mg + 180 mg. a > 5 kg chloroquine* Oral liquid: 50 mg/5 mL (as phosphate or sulfate). Tablet: 100 mg; 150 mg (as phosphate or sulfate). *For use only for the treatment of Plasmodium vivax infection. dihydroartemisinin + piperaquine phosphate a Tablet: 20 mg + 160 mg; 40 mg + 320 mg. a > 5 kg doxycycline* Capsule: 100 mg (as hydrochloride or hyclate). Tablet (dispersible): 100 mg (as monohydrate). *For use only in combination with quinine. mefloquine* Tablet: 250 mg (as hydrochloride). *To be used in combination with artesunate 50 mg. primaquine* Tablet: 7.5 mg; 15 mg (as diphosphate). *Only for use to achieve radical cure of Plasmodium vivax and Plasmodium ovale infections, given for 14 days. quinine* Injection: 300 mg/mL (hydrochloride) in 2 mL ampoule. Tablet: 300 mg (sulfate) or 300 mg (bisulfate). *For use only in the management of severe malaria and should be used in combination with doxycycline. sulfadoxine + pyrimethamine* Tablet: 500 mg + 25 mg. *Only in combination with artesunate 50 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 26 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 23 6.5.3.2 For chemoprevention amodiaquine – sulfadoxine + pyrimethamine [c] Co-packaged dispersible tablets: amodiaquine 76.5 mg (as hydrochloride) [3] and sulfadoxine + pyrimethamine 250 mg + 12.5 mg [1]; amodiaquine 153 mg (as hydrochloride) [3] and sulfadoxine + pyrimethamine 500 mg + 25 mg [1]. chloroquine* Oral liquid: 50 mg/5 mL (as phosphate or sulfate). Tablet: 150 mg (as phosphate or sulfate). *For use only in central American regions, for Plasmodium vivax infections. doxycycline a Solid oral dosage form: 100 mg (as hydrochloride or hyclate). a > 8 years. mefloquine a Tablet: 250 mg (as hydrochloride). a > 5 kg or > 3 months. proguanil* Tablet: 100 mg (as hydrochloride). *For use only in combination with chloroquine. sulfadoxine + pyrimethamine Tablet: 250 mg + 12.5 mg [c]; 500 mg + 25 mg. 6.5.4 Antipneumocystosis and antitoxoplasmosis medicines pyrimethamine Tablet: 25 mg. sulfadiazine Tablet: 500 mg. sulfamethoxazole + trimethoprim Injection: 80 mg + 16 mg/mL in 5 mL ampoule; 80 mg + 16 mg/mL in 10 mL ampoule. Oral liquid: 200 mg + 40 mg/5 mL [c]. Tablet: 100 mg + 20 mg; 400 mg + 80 mg [c]; 800 mg + 160 mg Complementary List pentamidine Tablet: 200 mg; 300 mg (as isethionate). 6.5.5 Antitrypanosomal medicines 6.5.5.1 African trypanosomiasis fexinidazole* Tablet: 600 mg *For the treatment of 1st and 2nd stage of human African trypanosomiasis due to Trypanosoma brucei gambiense infection. Medicines for the treatment of 1st stage African trypanosomiasis pentamidine* Powder for injection: 200 mg (as isetionate) in vial. *To be used for the treatment of Trypanosoma brucei gambiense infection. suramin sodium* Powder for injection: 1 g in vial. *To be used for the treatment of the initial phase ofTrypanosoma brucei rhodesiense infection. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 27 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 24 Medicines for the treatment of 2nd stage African trypanosomiasis eflornithine* Injection: 200 mg/mL (hydrochloride) in 100 mL bottle. *To be used for the treatment of Trypanosoma brucei gambiense infection. melarsoprol Injection: 180 mg/5 mL in 5 mL ampoule (3.6% solution). nifurtimox * Tablet: 120 mg. *Only to be used in combination with eflornithine, for the treatment of Trypanosoma brucei gambiense infection. Complementary List melarsoprol [c] Injection: 180 mg/5 mL in 5 mL ampoule (3.6% solution). 6.5.5.2 American trypanosomiasis benznidazole Tablet: 12.5 mg [c];100 mg. Tablet (scored): 50 mg. nifurtimox Tablet: 30 mg; 120 mg; 250 mg. 6.6 Medicines for ectoparasitic infections ivermectin Tablet (scored): 3 mg 7. ANTIMIGRAINE MEDICINES 7.1 For treatment of acute attack acetylsalicylic acid Tablet: 300 mg to 500 mg. ibuprofen [c] Tablet: 200 mg; 400 mg. paracetamol Oral liquid: 120 mg/5 mL [c]; 125 mg/5 mL [c]. Tablet: 300 mg to 500 mg. sumatriptan Tablet: 50 mg 7.2 For prophylaxis propranolol Therapeutic alternatives to be reviewed (2023) Tablet: 20 mg; 40 mg (hydrochloride). Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 28 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 25 8. IMMUNOMODULATORS AND ANTINEOPLASTICS 8.1 Immunomodulators for non-malignant disease Complementary List adalimumab* Therapeutic alternatives*: - certolizumab pegol - etanercept - golimumab - infliximab *including quality-assured biosimilars Injection: 40 mg/0.8 mL; 40 mg/0.4 mL. azathioprine Powder for injection: 100 mg (as sodium salt) in vial. Tablet (scored): 50 mg. ciclosporin Capsule: 25 mg. Concentrate for injection: 50 mg/mL in 1 mL ampoule. tacrolimus Capsule (immediate-release): 0.5 mg; 0.75 mg; 1 mg; 2 mg; 5 mg. Granules for oral supsension: 0.2 mg; 1 mg. Injection: 5 mg/mL in 1 mL vial. 8.2 Antineoplastics and supportive medicines Medicines listed below should be used according to protocols for treatment of the diseases. 8.2.1 Cytotoxic medicines Complementary List arsenic trioxide Concentrate for solution for infusion: 1 mg/mL − Acute promyelocytic leukaemia asparaginase* *including quality-assured biosimilars Powder for injection: 10 000 IU in vial. − Acute lymphoblastic leukaemia. bendamustine Injection: 45 mg/0.5 mL; 180 mg/2 mL. − Chronic lymphocytic leukaemia − Follicular lymphoma bleomycin Powder for injection: 15 mg (as sulfate) in vial. − Hodgkin lymphoma − Kaposi sarcoma − Ovarian germ cell tumour − Testicular germ cell tumour calcium folinate Injection: 3 mg/mL in 10 mL ampoule. Tablet: 5 mg; 15 mg; 25 mg. − Burkitt lymphoma − Early stage colon cancer − Early stage rectal cancer − Gestational trophoblastic neoplasia − Metastatic colorectal cancer − Osteosarcoma Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 29 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 26 capecitabine Tablet: 150 mg; 500 mg. − Early stage colon cancer − Early stage rectal cancer − Metastatic breast cancer − Metastatic colorectal cancer carboplatin Injection: 50 mg/5 mL; 150 mg/15 mL; 450 mg/45 mL; 600 mg/60 mL. − Cervical cancer − Early stage breast cancer − Epithelial ovarian cancer − Head and neck cancer (as a radio-sensitizer) − Low-grade glioma − Nasopharyngeal cancer − Nephroblastoma (Wilms tumour) − Non-small cell lung cancer − Osteosarcoma − Ovarian germ cell tumour − Retinoblastoma − Testicular germ cell tumour chlorambucil Tablet: 2 mg. − Chronic lymphocytic leukaemia cisplatin Injection: 10 mg/10 mL; 20 mg/20 mL; 50 mg/50 mL; 100 mg/100 mL. − Cervical cancer − Head and neck cancer (as a radio-sensitizer) − Low-grade glioma − Nasopharyngeal cancer (as a radio-sensitizer) − Non-small cell lung cancer − Osteosarcoma − Ovarian germ cell tumour − Testicular germ cell tumour cyclophosphamide Powder for injection: 500 mg; 1 g; 2 g in vial. Tablet: 25 mg, 50 mg. − Acute lymphoblastic leukaemia − Burkitt lymphoma − Chronic lymphocytic leukaemia − Diffuse large B-cell lymphoma − Early stage breast cancer − Ewing sarcoma − Follicular lymphoma − Gestational trophoblastic neoplasia − Hodgkin lymphoma − Low-grade glioma − Metastatic breast cancer − Multiple myeloma − Nephroblastoma (Wilms tumour) − Rhabdomyosarcoma cytarabine Powder for injection: 100 mg in vial. − Acute lymphoblastic leukaemia − Acute myeloid leukaemia − Acute promyelocytic leukaemia − Burkitt lymphoma. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 30 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 27 dacarbazine Powder for injection: 100 mg in vial. − Hodgkin lymphoma dactinomycin Powder for injection: 500 micrograms in vial. − Ewing sarcoma − Gestational trophoblastic neoplasia − Nephroblastoma (Wilms tumour) − Rhabdomyosarcoma daunorubicin Powder for injection: 50 mg (hydrochloride) in vial. − Acute lymphoblastic leukaemia − Acute myeloid leukaemia − Acute promyelocytic leukaemia docetaxel Injection: 20 mg/mL; 40 mg/mL. − Early stage breast cancer − Metastatic breast cancer − Metastatic prostate cancer doxorubicin Powder for injection: 10 mg; 50 mg (hydrochloride) in vial. − Acute lymphoblastic leukaemia − Burkitt lymphoma − Diffuse large B-cell lymphoma − Early stage breast cancer − Ewing sarcoma − Follicular lymphoma − Hodgkin lymphoma − Kaposi sarcoma − Metastatic breast cancer − Multiple myeloma − Nephroblastoma (Wilms tumour) − Osteosarcoma etoposide Capsule: 50 mg, 100 mg. Injection: 20 mg/mL in 5 mL ampoule. − Acute lymphoblastic leukaemia − Acute myeloid leukaemia − Burkitt lymphoma − Ewing sarcoma − Gestational trophoblastic neoplasia − Hodgkin lymphoma − Nephroblastoma (Wilms tumour) − Non-small cell lung cancer − Osteosarcoma − Ovarian germ cell tumour − Retinoblastoma − Testicular germ cell tumour fludarabine Powder for injection: 50 mg (phosphate) in vial. Tablet: 10 mg − Chronic lymphocytic leukaemia. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 31 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 28 fluorouracil Injection: 50 mg/mL in 5 mL ampoule. − Early stage breast cancer − Early stage colon cancer − Early stage rectal cancer − Metastatic colorectal cancer − Nasopharyngeal cancer gemcitabine Powder for injection: 200 mg; 1 g in vial. − Epithelial ovarian cancer − Non-small cell lung cancer hydroxycarbamide Solid oral dosage form: 200 mg; 250 mg; 300 mg; 400 mg; 500 mg; 1 g. − Chronic myeloid leukaemia ifosfamide Powder for injection: 500 mg; 1 g; 2 g in vial. − Burkitt lymphoma − Ewing sarcoma − Nephroblastoma (Wilms tumour) − Ovarian germ cell tumour − Osteosarcoma − Rhabdomyosarcoma − Testicular germ cell tumour irinotecan Injection: 40 mg/2 mL in 2 mL vial; 100 mg/5 mL in 5 mL vial; 500 mg/25 mL in 25 mL vial. − Metastatic colorectal cancer − Nephroblastoma (Wilms tumour) − Rhabdomyosarcoma melphalan Tablet: 2 mg Powder for injection: 50 mg in vial − Multiple myeloma. mercaptopurine Tablet: 50 mg. − Acute lymphoblastic leukaemia − Acute promyelocytic leukaemia. methotrexate Powder for injection: 50 mg (as sodium salt) in vial. Tablet: 2.5 mg (as sodium salt). − Acute lymphoblastic leukaemia − Acute promyelocytic leukaemia − Burkitt lymphoma − Early stage breast cancer − Gestational trophoblastic neoplasia − Osteosarcoma oxaliplatin Injection: 50 mg/10 mL in 10 mL vial; 100 mg/20 mL in 20 mL vial; 200 mg/40 mL in 40 mL vial. Powder for injection: 50 mg; 100 mg in vial. − Early stage colon cancer − Metastatic colorectal cancer Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 32 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 29 paclitaxel Injection: 6 mg/mL in vial. − Cervical cancer − Epithelial ovarian cancer − Early stage breast cancer − Metastatic breast cancer − Kaposi sarcoma − Nasopharyngeal cancer − Non-small cell lung cancer − Ovarian germ cell tumour pegaspargase* *including quality-assured biosimilars Injection: 3,750 units/5 mL in vial. − Acute lymphoblastic leukaemia procarbazine [c] Capsule: 50 mg (as hydrochloride). − Hodgkin lymphoma realgar-Indigo naturalis formulation Tablet: 270 mg (containing tetra-arsenic tetra-sulfide 30 mg). − Acute promyelocytic leukaemia tioguanine [c] Solid oral dosage form: 40 mg. − Acute lymphoblastic leukaemia vinblastine Injection: 10 mg/10 mL (sulfate) in vial. Powder for injection: 10 mg (sulfate) in vial. − Hodgkin lymphoma − Kaposi sarcoma − Low-grade glioma − Ovarian germ cell tumour − Testicular germ cell tumour vincristine Injection: 1 mg/mL (sulfate); 2 mg/2 mL (sulfate) in vial. Powder for injection: 1 mg; 5 mg (sulfate) in vial. − Acute lymphoblastic leukaemia − Burkitt lymphoma − Diffuse large B-cell lymphoma − Ewing sarcoma − Follicular lymphoma − Gestational trophoblastic neoplasia − Hodgkin lymphoma − Kaposi sarcoma − Low-grade glioma − Nephroblastoma (Wilms tumour) − Retinoblastoma − Rhabdomyosarcoma vinorelbine Capsule: 20 mg; 30 mg; 80 mg. Injection: 10 mg/mL in 1 mL vial; 50 mg/5 mL in 5 mL vial. − Non-small cell lung cancer − Metastatic breast cancer − Rhabdomyosarcoma Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 33 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 30 8.2.2 Targeted therapies Complementary List all-trans retinoid acid (ATRA) Capsule: 10 mg. − Acute promyelocytic leukaemia. bortezomib Powder for injection: 3.5 mg in vial. − Multiple myeloma dasatinib Tablet: 20 mg; 50 mg; 70 mg; 80 mg; 100 mg; 140 mg. − Imatinib-resistant chronic myeloid leukaemia erlotinib Therapeutic alternatives: - afatinib - gefitinib Tablet: 100 mg, 150 mg. − EGFR mutation-positive advanced non-small cell lung cancer everolimus Tablet: 2.5 mg; 5 mg; 7.5 mg; 10 mg. Tablet (dispersible): 2 mg; 3 mg; 5 mg. − Subependymal giant cell astrocytoma ibrutinib Capsule: 140 mg. − Relapsed/refractory chronic lymphocytic leukaemia imatinib Solid oral dosage form: 100 mg; 400 mg. − Chronic myeloid leukaemia − Gastrointestinal stromal tumour − Philadelphia chromosome positive acute lymphoblastic leukaemia nilotinib Capsule: 150 mg; 200 mg. − Imatinib-resistant chronic myeloid leukaemia rituximab* *including quality-assured biosimilars Injection (intravenous): 100 mg/10 mL in 10 mL vial; 500 mg/50 mL in 50 mL vial. − Diffuse large B-cell lymphoma − Chronic lymphocytic leukaemia − Follicular lymphoma trastuzumab* *including quality-assured biosimilars Powder for injection: 60 mg; 150 mg; 440 mg in vial. − Early stage HER2 positive breast cancer − Metastatic HER2 positive breast cancer Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 34 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 31 8.2.3 Immunomodulators Complementary List filgrastim* *including quality-assured biosimilars Injection: 120 micrograms/0.2 mL; 300 micrograms/0.5 mL; 480 micrograms/0.8 mL in pre-filled syringe. Injection: 300 micrograms/mL in 1 mL vial; 480 micrograms/1.6 mL in 1.6 mL vial. − Primary prophylaxis in patients at high risk for developing febrile neutropenia associated with myelotoxic chemotherapy. − Secondary prophylaxis for patients who have experienced neutropenia following prior myelotoxic chemotherapy − To facilitate administration of dose dense chemotherapy regimens lenalidomide Capsule: 25 mg. − Multiple myeloma nivolumab* Therapeutic alternatives*: - pembrolizumab *including quality-assured biosimilars Concentrate solution for infusion: 10 mg/mL. − Metastatic melanoma thalidomide Capsule: 50 mg. − Multiple myeloma 8.2.4 Hormones and antihormones Complementary List abiraterone Therapeutic alternatives: - enzalutamide Tablet: 250 mg; 500 mg. − Metastatic castration-resistant prostate cancer anastrozole Therapeutic alternatives: - 4th level ATC chemical subgroup (L02BG Aromatase inhibitors) Tablet: 1 mg. − Early stage breast cancer − Metastatic breast cancer bicalutamide Therapeutic alternatives: - flutamide - nilutamide Tablet: 50 mg. − Metastatic prostate cancer dexamethasone Injection: 4 mg/mL (as disodium phosphate salt) in 1 mL ampoule. Oral liquid: 2 mg/5 mL [c]. Tablet: 2 mg [c]; 4 mg. − Acute lymphoblastic leukaemia − Burkitt lymphoma − Multiple myeloma hydrocortisone Powder for injection: 100 mg (as sodium succinate) in vial. − Acute lymphoblastic leukaemia − Burkitt lymphoma Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 35 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 32 leuprorelin Therapeutic alternatives: - goserelin - triptorelin Injection: 7.5 mg; 22.5 mg in pre-filled syringe. − Early stage breast cancer − Metastatic prostate cancer. methylprednisolone [c] Injection: 40 mg/mL (as sodium succinate) in 1 mL single-dose vial and 5 mL multi-dose vials; 80 mg/mL (as sodium succinate) in 1 mL single-dose vial. − Acute lymphoblastic leukamia − Burkitt lymphoma prednisolone Therapeutic alternatives: - prednisone Oral liquid: 5 mg/mL [c]. Tablet: 5 mg; 25 mg. − Acute lymphoblastic leukaemia − Burkitt lymphoma − Chronic lymphocytic leukaemia − Diffuse large B-cell lymphoma − Follicular lymphoma − Hodgkin lymphoma − Metastatic castration-resitsant prostate cancer − Multiple myeloma tamoxifen Tablet: 10 mg; 20 mg (as citrate). − Early stage breast cancer − Metastatic breast cancer. 8.2.5 Supportive medicines Complementary List allopurinol [c] Tablet: 100 mg; 300 mg. − Tumour lysis syndrome mesna Injection: 100 mg/mL in 4 mL and 10 mL ampoules. Tablet: 400 mg; 600 mg. − Burkitt lymphoma − Ewing sarcoma − Nephroblastoma (Wilms tumour) − Ovarian germ cell tumour − Osteosarcoma − Rhabdomyosarcoma − Testicular germ cell tumour rasburicase Powder and solvent for solution for infusion: 1.5 mg; 7.5 mg in vial − Tumour lysis syndrome zoledronic acid Concentrate solution for infusion: 4 mg/5 mL in 5 mL vial. Solution for infusion: 4 mg/100 mL in 100 mL bottle. − Malignancy-related bone disease Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 36 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 33 9. ANTIPARKINSONISM MEDICINES biperiden Therapeutic alternatives: − trihexyphenidyl Injection: 5 mg (lactate) in 1 mL ampoule. Tablet: 2 mg (hydrochloride). levodopa + carbidopa Therapeutic alternatives: − benserazide (for carbidopa) Tablet: 100 mg + 10 mg; 100 mg + 25 mg; 250 mg + 25 mg. 10. MEDICINES AFFECTING THE BLOOD 10.1 Antianaemia medicines ferrous salt Oral liquid: equivalent to 25 mg iron (as sulfate)/mL. Tablet: equivalent to 60 mg iron. ferrous salt + folic acid Tablet: equivalent to 60 mg iron + 400 micrograms folic acid. *nutritional supplement for use during pregnancy folic acid Tablet: 400 micrograms*; 1 mg; 5 mg. *periconceptual use for prevention of first occurrence of neural tube defects hydroxocobalamin Injection: 1 mg/mL (as acetate, as hydrochloride or as sulfate) in 1 mL ampoule. Complementary List erythropoiesis-stimulating agents* Therapeutic alternatives: - epoetin alfa, beta and theta - darbepoetin alfa - methoxy polyethylene glycol-epoetin beta *including quality-assured biosimilars Injection: pre-filled syringe 1000 IU/0.5 mL; 2000 IU/0.5 mL; 3000 IU/0.3 mL; 4000 IU/0.4 mL; 5000 IU/0.5 mL; 6000 IU/0.6 mL; 8000 IU/0.8mL; 10 000 IU/1 mL; 20 000 IU/0.5 mL; 40 000 IU/1 mL. 10.2 Medicines affecting coagulation dabigatran Therapeutic alternatives: - apixaban - edoxaban - rivaroxaban Capsule: 110 mg; 150 mg. enoxaparin* Therapeutic alternatives*: - dalteparin - nadroparin *including quality-assured biosimilars Injection: ampoule or pre-filled syringe 20 mg/0.2 mL; 40 mg/0.4 mL; 60 mg/0.6 mL; 80 mg/0.8 mL; 100 mg/1 mL; 120 mg/0.8 mL; 150 mg/1 mL. heparin sodium Injection: 1000 IU/mL; 5000 IU/mL; 20 000 IU/mL in 1 mL ampoule. phytomenadione Injection: 1 mg/mL [c]; 10 mg/mL in ampoule. Tablet: 10 mg. protamine sulfate Injection: 10 mg/mL in 5 mL ampoule. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 37 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 34 tranexamic acid Injection: 100 mg/mL in 10 mL ampoule. warfarin Therapeutic alternatives to be reviewed (2023) Tablet: 1 mg; 2 mg; 5 mg (sodium). Complementary List desmopressin[c] Injection: 4 micrograms/mL (as acetate) in 1 mL ampoule. Nasal spray: 10 micrograms (as acetate) per dose. heparin sodium [c] Injection: 1000 IU/mL; 5000 IU/mL in 1 mL ampoule. protamine sulfate [c] Injection: 10 mg/mL in 5 mL ampoule. warfarin [c] Therapeutic alternatives to be reviewed (2023) Tablet: 0.5 mg; 1 mg; 2 mg; 5 mg (sodium). 10.3 Other medicines for haemoglobinopathies Complementary List deferoxamine Therapeutic alternatives: - deferasirox (oral) Powder for injection: 500 mg (mesilate) in vial. hydroxycarbamide Solid oral dosage form: 200 mg; 500 mg; 1 g. 11. BLOOD PRODUCTS OF HUMAN ORIGIN AND PLASMA SUBSTITUTES 11.1 Blood and blood components In accordance with the World Health Assembly resolution WHA63.12, WHO recognizes that achieving self-sufficiency, unless special circumstances preclude it, in the supply of safe blood components based on voluntary, non-remunerated blood donation, and the security of that supply are important national goals to prevent blood shortages and meet the transfusion requirements of the patient population. All preparations should comply with the WHO requirements. fresh-frozen plasma platelets red blood cells whole blood 11.2 Plasma-derived medicines All human plasma-derived medicines should comply with the WHO requirements. 11.2.1 Human immunoglobulins anti-D immunoglobulin Injection: 250 micrograms in single-dose vial. anti-rabies immunoglobulin Injection: 150 IU/mL in vial. anti-tetanus immunoglobulin Injection: 500 IU in vial. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 38 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 35 Complementary List normal immunoglobulin Intramuscular administration: 16% protein solution.* Intravenous administration: 5%; 10% protein solution.** Subcutaneous administration: 15%; 16% protein solution.* *Indicated for primary immune deficiency. **Indicated for primary immune deficiency and Kawasaki disease. 11.2.2 Blood coagulation factors Complementary List coagulation factor VIII Therapeutic alternatives to be reviewed (2023) Powder for injection: 500 IU/vial. coagulation factor IX Therapeutic alternatives to be reviewed (2023) Powder for injection: 500 IU/vial, 1000 IU/vial. 11.3 Plasma substitutes dextran 70 Therapeutic alternatives: - Polygeline injectable solution 3.5% Injectable solution: 6%. 12. CARDIOVASCULAR MEDICINES 12.1 Antianginal medicines bisoprolol Therapeutic alternatives: - carvedilol - metoprolol Tablet: 1.25 mg; 5 mg. glyceryl trinitrate Tablet (sublingual): 500 micrograms. isosorbide dinitrate Tablet (sublingual): 5 mg. verapamil Tablet: 40 mg; 80 mg (hydrochloride). 12.2 Antiarrhythmic medicines bisoprolol Therapeutic alternatives: - carvedilol - metoprolol Tablet: 1.25 mg; 5 mg. digoxin Injection: 250 micrograms/mL in 2 mL ampoule. Oral liquid: 50 micrograms/mL. Tablet: 62.5 micrograms; 250 micrograms. epinephrine (adrenaline) Injection: 100 micrograms/mL (as acid tartrate or hydrochloride) in 10 mL ampoule. lidocaine Injection: 20 mg/mL (hydrochloride) in 5 mL ampoule. verapamil Injection: 2.5 mg/mL (hydrochloride) in 2 mL ampoule. Tablet: 40 mg; 80 mg (hydrochloride). Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 39 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 36 Complementary List amiodarone Injection: 50 mg/mL (hydrochloride) in 3 mL ampoule. Tablet: 100 mg; 200 mg; 400 mg (hydrochloride). 12.3 Antihypertensive medicines amlodipine Therapeutic alternatives: - 4th level ATC chemical subgroup (C08CA Dihydropyridine derivatives) Tablet: 5 mg (as maleate, mesylate or besylate). bisoprolol Therapeutic alternatives: - atenolol* - carvedilol - metoprolol Tablet: 1.25 mg; 5 mg. *atenolol should not be used as a first-line agent in uncomplicated hypertension in patients > 60 years enalapril Therapeutic alternatives: - 4th level ATC chemical subgroup (C09AA ACE inhibitors, plain) Tablet: 2.5 mg; 5 mg (as hydrogen maleate). hydralazine* Powder for injection: 20 mg (hydrochloride) in ampoule. Tablet: 25 mg; 50 mg (hydrochloride). *Hydralazine is listed for use only in the acute management of severe pregnancy-induced hypertension. Its use in the treatment of essential hypertension is not recommended in view of the evidence of greater efficacy and safety of other medicines. hydrochlorothiazide Therapeutic alternatives: - chlorothiazide - chlorthalidone - indapamide Oral liquid: 50 mg/5 mL. Solid oral dosage form: 12.5 mg; 25 mg. lisinopril + amlodipine Therapeutic alternatives: - 4th level ATC chemical subgroup (C09AA ACE inhibitors, plain) (for lisinopril) - 4th level ATC chemical subgroup (C08CA Dihydropyridine derivatives) (for amlodipine) Tablet: 10 mg + 5 mg; 20 mg + 5 mg; 20 mg + 10 mg. lisinopril + hydrochlorothiazide Therapeutic alternatives: - 4th level ATC chemical subgroup (C09AA ACE inhibitors, plain) (for lisinopril) - chlorthalidone, chlorothiazide, indapamide (for hydrochlorothiazide) Tablet: 10 mg + 12.5 mg; 20 mg + 12.5 mg; 20 mg + 25 mg. losartan Therapeutic alternatives: - 4th level ATC chemical subgroup (C09CA Angiotensin II receptor blockers (ARBs), plain) Tablet: 25 mg; 50 mg; 100 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 40 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 37 methyldopa* Tablet: 250 mg. *Methyldopa is listed for use only in the management of pregnancy- induced hypertension. Its use in the treatment of essential hypertension is not recommended in view of the evidence of greater efficacy and safety of other medicines. telmisartan + amlodipine Therapeutic alternatives: - 4th level ATC chemical subgroup (C09CA Angiotensin II receptor blockers (ARBs), plain) (for telmisartan) - 4th level ATC chemical subgroup (C08CA Dihydropyridine derivatives) (for amlodipine) Tablet: 40 mg + 5 mg; 80 mg + 5 mg; 80 mg + 10 mg. telmisartan + hydrochlorothiazide Therapeutic alternatives: - 4th level ATC chemical subgroup (C09CA Angiotensin II receptor blockers (ARBs), plain) (for telmisartan) - chlorthalidone, chlorothiazide, indapamide (for hydrochlorothiazide) Tablet: 40 mg + 12.5 mg; 80 mg + 12.5 mg; 80 mg + 25 mg. Complementary List sodium nitroprusside Powder for infusion: 50 mg in ampoule. 12.4 Medicines used in heart failure bisoprolol Therapeutic alternatives: - carvedilol - metoprolol Tablet: 1.25 mg; 5 mg. digoxin Injection: 250 micrograms/mL in 2 mL ampoule. Oral liquid: 50 micrograms/mL. Tablet: 62.5 micrograms; 250 micrograms. enalapril Therapeutic alternatives: - 4th level ATC chemical subgroup (C09AA ACE inhibitors, plain) Tablet: 2.5 mg; 5 mg (as hydrogen maleate). furosemide Therapeutic alternatives: - bumetanide - torasemide Injection: 10 mg/mL in 2 mL ampoule. Oral liquid: 20 mg/5 mL [c]. Tablet: 40 mg. hydrochlorothiazide Therapeutic alternatives: - chlorothiazide - chlorthalidone - indapamide Oral liquid: 50 mg/5 mL. Solid oral dosage form: 25 mg. losartan Therapeutic alternatives: - 4th level ATC chemical subgroup (C09CA Angiotensin II receptor blockers (ARBs), plain) Tablet: 25 mg; 50 mg; 100 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 41 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 38 spironolactone Tablet: 25 mg. Complementary List dopamine Injection: 40 mg/mL (hydrochloride) in 5 mL vial. 12.5 Antithrombotic medicines 12.5.1 Anti-platelet medicines acetylsalicylic acid Tablet: 100 mg. clopidogrel Tablet: 75 mg; 300 mg 12.5.2 Thrombolytic medicines Complementary List alteplase Powder for injection: 10 mg; 20 mg; 50 mg in vial streptokinase Powder for injection: 1.5 million IU in vial. 12.6 Lipid-lowering agents simvastatin* Therapeutic alternatives: - atorvastatin - fluvastatin - lovastatin - pravastatin Tablet: 5 mg; 10 mg; 20 mg; 40 mg. *For use in high-risk patients. 13. DERMATOLOGICAL MEDICINES (topical) 13.1 Antifungal medicines miconazole Therapeutic alternatives: - 4th level ATC chemical subgroup (D01AC Imidazole and triazole derivatives) excluding combinations Cream or ointment: 2% (nitrate). selenium sulfide Detergent-based suspension: 2%. sodium thiosulfate Solution: 15%. terbinafine Cream or ointment: 1% (hydrochloride). Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 42 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 39 13.2 Anti-infective medicines mupirocin Cream: 2% (as calcium). Ointment: 2%. potassium permanganate Aqueous solution: 1:10 000. silver sulfadiazine a Cream: 1%. a > 2 months. 13.3 Anti-inflammatory and antipruritic medicines betamethasone a Therapeutic alternatives: - 4th level ATC chemical subgroup (D07AC Corticosteroids, potent (group III)) Cream or ointment: 0.1% (as valerate). a Hydrocortisone preferred in neonates. calamine Lotion. hydrocortisone Therapeutic alternatives: - 4th level ATC chemical subgroup (D07AA Corticosteroids, weak (group I)) Cream or ointment: 1% (acetate). 13.4 Medicines affecting skin differentiation and proliferation benzoyl peroxide Cream or lotion: 5%. calcipotriol Therapeutic alternatives: - calcitriol - tacalcitol Cream or ointment: 50 micrograms/mL (0.005%). Lotion: 50 micrograms/mL (0.005%). coal tar Solution: 5%. fluorouracil Ointment: 5%. podophyllum resin Therapeutic alternatives: - podophyllotoxin Solution: 10% to 25%. salicylic acid Solution: 5%. urea Cream or ointment: 5%; 10%. 13.5 Scabicides and pediculicides benzyl benzoate a Therapeutic alternatives: - precipitated sulfur topical ointment Lotion: 25%. a > 2 years. permethrin Cream: 5%. Lotion: 1%. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 43 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 40 14. DIAGNOSTIC AGENTS 14.1 Ophthalmic medicines fluorescein Eye drops: 1% (sodium salt). tropicamide Therapeutic alternatives: - atropine - cyclopentolate Eye drops: 0.5%. 14.2 Radiocontrast media amidotrizoate Therapeutic alternatives to be reviewed (2023) Injection: 140 mg to 420 mg iodine/mL (as sodium or meglumine salt) in 20 mL ampoule. barium sulfate Aqueous suspension. iohexol Therapeutic alternatives to be reviewed (2023) Injection: 140 mg to 350 mg iodine/mL in 5 mL; 10 mL; 20 mL ampoules. Complementary List barium sulfate [c] Aqueous suspension. meglumine iotroxate Therapeutic alternatives to be reviewed (2023) Solution: 5 g to 8 g iodine in 100 mL to 250 mL. 15. ANTISEPTICS AND DISINFECTANTS 15.1 Antiseptics chlorhexidine Therapeutic alternatives to be reviewed (2023) Solution: 5% (digluconate). ethanol Therapeutic alternatives: - propanol Solution: 70% (denatured). povidone iodine Therapeutic alternatives: - iodine Solution: 10% (equivalent to 1% available iodine). 15.2 Disinfectants alcohol based hand rub Solution: containing ethanol 80% volume/volume. Solution: containing isopropyl alcohol 75% volume/volume. chlorine base compound Liquid: (0.1% available chlorine) for solution. Powder: (0.1% available chlorine) for solution. Solid: (0.1% available chlorine) for solution. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 44 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 41 chloroxylenol Therapeutic alternatives: - 4th level ATC chemical subgroup (D08AE Phenol and derivatives) Solution: 4.8%. glutaral Solution: 2%. 16. DIURETICS amiloride Tablet: 5 mg (hydrochloride). furosemide Therapeutic alternatives: - bumetanide - torasemide Injection: 10 mg/mL in 2 mL ampoule. Oral liquid: 20 mg/5 mL [c]. Tablet: 10 mg [c]; 20 mg [c]; 40 mg. hydrochlorothiazide Therapeutic alternatives: - chlorothiazide - chlortalidone - indapamide Solid oral dosage form: 25 mg. mannitol Injectable solution: 10%; 20%. spironolactone Tablet: 25 mg. Complementary List hydrochlorothiazide[c] Therapeutic alternatives: - chlorothiazide - chlortalidone Tablet (scored): 25 mg. mannitol [c] Injectable solution: 10%; 20%. spironolactone[c] Oral liquid: 5 mg/5 mL; 10 mg/5 mL; 25 mg/5 mL. Tablet: 25 mg. 17. GASTROINTESTINAL MEDICINES Complementary List pancreatic enzymes[c] Age-appropriate formulations and doses including lipase, protease and amylase. 17.1 Antiulcer medicines omeprazole Therapeutic alternatives: - 4th level ATC chemical subgroup (A02BC Proton pump inhibitors) excluding combinations Powder for injection: 40 mg in vial Powder for oral liquid: 20 mg; 40 mg sachets. Solid oral dosage form: 10 mg; 20 mg; 40 mg. ranitidine Therapeutic alternatives: - 4th level ATC chemical subgroup (A02BA H2-receptor antagonists) excluding combinations Injection: 25 mg/mL (as hydrochloride) in 2 mL ampoule. Oral liquid: 75 mg/5 mL (as hydrochloride). Tablet: 150 mg (as hydrochloride). Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 45 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 42 17.2 Antiemetic medicines dexamethasone Injection: 4 mg/mL (as disodium phosphate salt) in 1 mL ampoule. Oral liquid: 0.5 mg/5 mL; 2 mg/5 mL. Solid oral dosage form: 0.5 mg; 0.75 mg; 1.5 mg; 4 mg. metoclopramide a Injection: 5 mg/mL (hydrochloride) in 2 mL ampoule. Oral liquid: 5 mg/5 mL [c]. Tablet: 10 mg (hydrochloride). a Not in neonates. ondansetron a Therapeutic alternatives: - dolasetron - granisetron - palonosetron - tropisetron Injection: 2 mg base/mL in 2 mL ampoule (as hydrochloride). Oral liquid: 4 mg base/5 mL. Solid oral dosage form: Eq 4 mg base; Eq 8 mg base; Eq 24 mg base. a > 1 month. Complementary list aprepitant Capsule: 80 mg; 125 mg; 165 mg Powder for oral susupension: 125 mg in sachet 17.3 Anti-inflammatory medicines sulfasalazine Therapeutic alternatives: - mesalazine Retention enema. Suppository: 500 mg. Tablet: 500 mg. Complementary List hydrocortisone Retention enema: 100 mg/60 mL. Suppository: 25 mg (acetate). prednisolone Retention enema: 20 mg/100 mL (as sodium phosphate). 17.4 Laxatives senna Therapeutic alternatives: - bisacodyl Tablet: 7.5 mg (sennosides) (or traditional dosage forms). 17.5 Medicines used in diarrhoea oral rehydration salts – zinc sulfate [c] Co-package containing: ORS powder for dilution (see Section 17.5.1) – zinc sulfate solid oral dosage form 20 mg (see Section 17.5.2) Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 46 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 43 17.5.1 Oral rehydration oral rehydration salts Powder for dilution in 200 mL; 500 mL; 1 L. glucose: 75 mEq sodium: 75 mEq or mmol/L chloride: 65 mEq or mmol/L potassium: 20 mEq or mmol/L citrate: 10 mmol/L osmolarity: 245 mOsm/L glucose: 13.5 g/L sodium chloride: 2.6 g/L potassium chloride: 1.5 g/L trisodium citrate dihydrate*: 2.9 g/L *trisodium citrate dihydrate may be replaced by sodium hydrogen carbonate (sodium bicarbonate) 2.5 g/L. However, as the stability of this latter formulation is very poor under tropical conditions, it is recommended only when manufactured for immediate use. 17.5.2 Medicines for diarrhoea zinc sulfate* Solid oral dosage form: 20 mg. *In acute diarrhoea zinc sulfate should be used as an adjunct to oral rehydration salts. 18. MEDICINES FOR ENDOCRINE DISORDERS 18.1 Adrenal hormones and synthetic substitutes fludrocortisone Tablet: 100 micrograms (acetate). hydrocortisone Tablet: 5 mg; 10 mg; 20 mg. 18.2 Androgens Complementary List testosterone Injection: 200 mg (enanthate) in 1 mL ampoule. 18.3 Estrogens 18.4 Progestogens medroxyprogesterone acetate Therapeutic alternatives: - norethisterone Tablet: 5 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 47 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 44 18.5 Medicines for diabetes 18.5.1 Insulins insulin injection (soluble)* *including quality-assured biosimilars Injection: 40 IU/mL in 10 mL vial; 100 IU/mL in 10 mL vial. intermediate-acting insulin* *including quality-assured biosimilars Injection: 40 IU/mL in 10 mL vial; 100 IU/mL in 10 mL vial (as compound insulin zinc suspension or isophane insulin). long-acting insulin analogues* Therapeutic alternatives: - insulin degludec - insulin detemir - insulin glargine *including quality-assured biosimilars Injection: 100 IU/mL in 3 mL cartridge or pre-filled pen. 18.5.2 Oral hypoglycaemic agents empagliflozin Therapeutic alternatives: - canagliflozin - dapagliflozin Tablet: 10 mg; 25 mg. gliclazide* Therapeutic alternatives: - 4th level ATC chemical subgroup (A10BB Sulfonylureas) Solid oral dosage form: (controlled-release tablets) 30 mg; 60 mg; 80 mg. *glibenclamide not suitable above 60 years. metformin Tablet: 500 mg (hydrochloride). Complementary List metformin [c] Tablet: 500 mg (hydrochloride). 18.6 Medicines for hypoglycaemia glucagon Injection: 1 mg/mL. Complementary List diazoxide [c] Oral liquid: 50 mg/mL. Tablet: 50 mg. 18.7 Thyroid hormones and antithyroid medicines levothyroxine Tablet: 25 micrograms [c]; 50 micrograms; 100 micrograms (sodium salt). potassium iodide Tablet: 60 mg. methimazole Therapeutic alternatives: - carbimazole (depending on local availability) Tablet: 5mg, 10mg, 20mg. propylthiouracil* Tablet: 50 mg. *For use when alternative first-line treatment is not appropriate or available; and in patients during the first trimester of pregnancy. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 48 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 45 Complementary List Lugol's solution [c] Oral liquid: about 130 mg total iodine/mL. methimazole [c] Therapeutic alternatives: - carbimazole (depending on local availability) Tablet: 5mg, 10mg, 20mg. potassium iodide [c] Tablet: 60 mg. propylthiouracil* [c] Tablet: 50 mg. *For use when alternative first-line treatment is not appropriate or available 19. IMMUNOLOGICALS 19.1 Diagnostic agents All tuberculins should comply with the WHO requirements for tuberculins. tuberculin, purified protein derivative (PPD) Injection. 19.2 Sera, immunoglobulins and monoclonal antibodies All plasma fractions should comply with the WHO requirements. anti-rabies virus monoclonal antibodies* *including quality-assured biosimilars Injection: 40 IU/mL in 1.25 mL, 2.5 mL vial; 100 IU/mL in 2.5 mL vial (human). Injection: 300 IU/mL in 10 mL vial; 600 IU/mL in 1 mL, 2.5 mL and 5 mL vial (murine). antivenom immunoglobulin* Injection. *Exact type to be defined locally. diphtheria antitoxin Injection: 10 000 IU; 20 000 IU in vial. equine rabies immunoglobulin Injection: 150 IU/mL; 200 IU/mL; 300 IU/mL; 400 IU/mL in vial. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 49 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 46 19.3 Vaccines WHO immunization policy recommendations are published in vaccine position papers based on recommendations made by the Strategic Advisory Group of Experts on Immunization (SAGE). WHO vaccine position papers are updated three to four times per year. The list below details the vaccines for which there is a recommendation from SAGE and a corresponding WHO position paper as at September 2020. The most recent versions of the WHO position papers, reflecting the current evidence related to a specific vaccine and the related recommendations, can be accessed at any time on the WHO website at: https://www.who.int/teams/immunization-vaccines-and-biologicals/policies/position-papers Vaccine recommendations may be universal or conditional (e.g., in certain regions, in some high-risk populations or as part of immunization programmes with certain characteristics). Details are available in the relevant position papers, and in the Summary Tables of WHO Routine Immunization Recommendations available on the WHO website at: https://www.who.int/teams/immunization-vaccines-and-biologicals/policies/who-recommendations-for-routine-immunization---summary- tables Selection of vaccines from the Model List will need to be determined by each country after consideration of international recommendations, epidemiology and national priorities. All vaccines should comply with the WHO requirements for biological substances. WHO noted the need for vaccines used in children to be polyvalent. Recommendations for all BCG vaccine diphtheria vaccine Haemophilus influenzae type b vaccine hepatitis B vaccine human papilloma virus (HPV) vaccine measles vaccine pertussis vaccine pneumococcal vaccine poliomyelitis vaccine rotavirus vaccine rubella vaccine tetanus vaccine Recommendations for certain regions Japanese encephalitis vaccine tick-borne encephalitis vaccine yellow fever vaccine Recommendations for some high-risk populations cholera vaccine dengue vaccine hepatitis A vaccine meningococcal meningitis vaccine Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 50 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 47 rabies vaccine typhoid vaccine Recommendations for immunization programmes with certain characteristics influenza vaccine (seasonal) mumps vaccine varicella vaccine 20. MUSCLE RELAXANTS (PERIPHERALLY-ACTING) AND CHOLINESTERASE INHIBITORS atracurium Therapeutic alternatives to be reviewed (2023) Injection: 10 mg/mL (besylate). neostigmine Injection: 500 micrograms/mL (methylsulfate) in 1 mL ampoule; 2.5 mg/mL (methylsulfate) in 1 mL ampoule. Tablet: 15 mg (bromide). suxamethonium Injection: 50 mg/mL (chloride) in 2 mL ampoule. Powder for injection: (chloride), in vial. vecuronium [c] Therapeutic alternatives to be reviewed (2023) Powder for injection: 10 mg (bromide) in vial. Complementary List pyridostigmine Injection: 1 mg in 1 mL ampoule. Tablet: 60 mg (bromide). vecuronium Therapeutic alternatives to be reviewed (2023) Powder for injection: 10 mg (bromide) in vial. 21. OPHTHALMOLOGICAL PREPARATIONS 21.1 Anti-infective agents aciclovir Ointment: 3% W/W. azithromycin Solution (eye drops): 1.5%. − Trachoma erythromycin Ointment: 0.5% [c] − Infections due to Chlamydia trachomatis or Neisseria gonorrhoea. gentamicin Therapeutic alternatives: - amikacin - kanamycin - netilmicin - tobramycin Solution (eye drops): 0.3% (sulfate). − Bacterial blepharitis − Bacterial conjunctivitis Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 51 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 48 natamycin Suspension (eye drops): 5% − Fungal keratitis ofloxacin Therapeutic alternatives: - 4th level ATC chemical subgroup (S01AE Fluoroquinolones) Solution (eye drops): 0.3%. − Bacterial conjunctivitis − Bacterial keratitis tetracycline Therapeutic alternatives: - chlortetracycline - oxytetracycline Eye ointment: 1% (hydrochloride). − Bacterial blepharitis − Bacterial conjunctivitis − Bacterial keratitis − Trachoma 21.2 Anti-inflammatory agents prednisolone Therapeutic alternatives to be reviewed (2023) Solution (eye drops): 0.5% (sodium phosphate). 21.3 Local anaesthetics tetracaine a Therapeutic alternatives: - 4th level ATC chemical subgroup (S01HA Local anaesthetics) excluding cocaine and combinations Solution (eye drops): 0.5% (hydrochloride). a Not in preterm neonates. 21.4 Miotics and antiglaucoma medicines acetazolamide Tablet: 250 mg. latanoprost Solution (eye drops): 50 micrograms/mL pilocarpine Therapeutic alternatives: - carbachol Solution (eye drops): 2%; 4% (hydrochloride or nitrate). timolol Therapeutic alternatives: - 4th level ATC chemical subgroup (S01ED Beta blocking agents) excluding combinations Solution (eye drops): 0.25%; 0.5% (as hydrogen maleate). 21.5 Mydriatics atropine a Therapeutic alternatives*: - cyclopentolate hydrochloride - homatropine hydrobromide *EMLc only Solution (eye drops): 0.1%; 0.5%; 1% (sulfate). a > 3 months. Complementary List epinephrine (adrenaline) Solution (eye drops): 2% (as hydrochloride). 21.6 Anti-vascular endothelial growth factor (VEGF) preparations Complementary List bevacizumab* *including quality-assured biosimilars Injection: 25 mg/mL. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 52 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 49 22. MEDICINES FOR REPRODUCTIVE HEALTH AND PERINATAL CARE 22.1 Contraceptives 22.1.1 Oral hormonal contraceptives ethinylestradiol + levonorgestrel Therapeutic alternatives to be reviewed (2023) Tablet: 30 micrograms + 150 micrograms. ethinylestradiol + norethisterone Therapeutic alternatives to be reviewed (2023) Tablet: 35 micrograms + 1 mg. levonorgestrel Tablet: 30 micrograms; 750 micrograms (pack of two); 1.5 mg. ulipristal Tablet: 30 mg (as acetate) 22.1.2 Injectable hormonal contraceptives estradiol cypionate + medroxyprogesterone acetate Injection: 5 mg + 25 mg. medroxyprogesterone acetate Injection (intramuscular): 150 mg mL in 1 mL vial. Injection (subcutaneous): 104 mg/0.65 mL in pre-filled syringe or single-dose injection delivery system. norethisterone enantate Oily solution: 200 mg/mL in 1 mL ampoule. 22.1.3 Intrauterine devices copper-containing device levonorgestrel-releasing intrauterine system Intrauterine system: with reservoir containing 52 mg of levonorestrel 22.1.4 Barrier methods condoms diaphragms 22.1.5 Implantable contraceptives etonogestrel-releasing implant Single-rod etonogestrel-releasing implant: containing 68 mg of etonogestrel. levonorgestrel-releasing implant Two-rod levonorgestrel-releasing implant: each rod containing 75 mg of levonorgestrel (150 mg total). 22.1.6 Intravaginal contraceptives ethinylestradiol + etonogestrel Vaginal ring: containing 2.7 mg + 11.7 mg progesterone vaginal ring* Progesterone-releasing vaginal ring: containing 2.074 g of micronized progesterone. *For use in women actively breastfeeding at least 4 times per day 22.2 Ovulation inducers Complementary List clomifene Tablet: 50 mg (citrate). Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 53 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 50 22.3 Uterotonics carbetocin Injection (heat stable): 100 micrograms/mL ergometrine Therapeutic alternatives: - methylergometrine Injection: 200 micrograms (hydrogen maleate) in 1 mL ampoule. mifepristone – misoprostol Where permitted under national law and where culturally acceptable. Tablet 200 mg – tablet 200 micrograms. Co-package containing: mifepristone 200 mg tablet [1] and misoprostol 200 micrograms tablet [4] misoprostol Tablet: 200 micrograms. − Management of incomplete abortion and miscarriage; − Prevention and treatment of postpartum haemorrhage where oxytocin is not available or cannot be safely used Vaginal tablet: 25 micrograms.* *Only for use for induction of labour where appropriate facilities are available. oxytocin Injection: 10 IU in 1 mL. 22.4 Antioxytocics (tocolytics) nifedipine Immediate-release capsule: 10 mg. 22.5 Other medicines administered to the mother dexamethasone Injection: 4 mg/mL (as disodium phosphate salt) in 1 mL ampoule. multiple micronutrient supplement* Tablet containing: Vitamin A (retinol acetate) 800 micrograms retinol activity equivalent Vitamin C (ascorbic acid) 70 mg Vitamin D (cholecalciferol) 5 micrograms (200 IU) Vitamin E (alpha tocopherol succinate) 10 mg alpha tocopherol equivalent Vitamin B1 (thiamine mononitrate) 1.4 mg Vitamin B2 (riboflavin) 1.4 mg Vitamin B3 (niacinamide) 18 mg niacin equivalent Vitamin B6 (pyridoxine hydrochloride) 1.9 mg Folic acid (folic acid) 680 micrograms dietary folate equivalent (400 micrograms) Vitamin B12 (cyanocobalamin) 2.6 micrograms Iron (ferrous fumarate) 30 mg Iodine (potassium iodide) 150 micrograms Zinc (zinc oxide) 15 mg Selenium (sodium selenite) 65 micrograms Copper (cupric oxide) 2 mg *For use in specific contexts. Refer to current WHO recommendations. tranexamic acid Injection: 100 mg/mL in 10 mL ampoule 22.6 Medicines administered to the neonate [c] caffeine citrate [c] Injection: 20 mg/mL (equivalent to 10 mg caffeine base/mL). Oral liquid: 20 mg/mL (equivalent to 10 mg caffeine base/mL). chlorhexidine [c] Solution or gel: 7.1% (digluconate) delivering 4% chlorhexidine (for umbilical cord care). Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 54 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 51 Complementary List ibuprofen [c] Therapeutic alternatives: - indometacin Solution for injection: 5 mg/mL. prostaglandin E1 [c] Therapeutic alternatives: - prostaglandin E2 Solution for injection: 0.5 mg/mL in alcohol. surfactant [c] Suspension for intratracheal instillation: 25 mg/mL or 80 mg/mL. 23. PERITONEAL DIALYSIS SOLUTION Complementary List intraperitoneal dialysis solution (of appropriate composition) Parenteral solution. 24. MEDICINES FOR MENTAL AND BEHAVIOURAL DISORDERS 24.1 Medicines used in psychotic disorders chlorpromazine Therapeutic alternatives to be reviewed (2023) Injection: 25 mg/mL (hydrochloride) in 2 mL ampoule. Oral liquid: 25 mg/5 mL (hydrochloride). Tablet: 100 mg (hydrochloride). fluphenazine Therapeutic alternatives to be reviewed (2023) Injection: 25 mg (decanoate or enantate) in 1 mL ampoule. haloperidol Therapeutic alternatives to be reviewed (2023) Injection: 5 mg in 1 mL ampoule. Tablet: 2 mg; 5 mg. paliperidone Therapeutic alternatives: - risperidone injection Injection (prolonged-release): 25 mg; 50 mg; 75 mg; 100 mg; 150 mg (as palmitate) in pre-filled syringe risperidone Solid oral dosage form: 0.25 mg to 6.0 mg. Complementary List chlorpromazine [c] Injection: 25 mg/mL (hydrochloride) in 2 mL ampoule. Oral liquid: 25 mg/5 mL (hydrochloride). Tablet: 10 mg; 25 mg; 50 mg; 100 mg (hydrochloride). clozapine Solid oral dosage form: 25 to 200 mg. haloperidol [c] Injection: 5 mg in 1 mL ampoule. Oral liquid: 2 mg/mL. Solid oral dosage form: 0.5 mg; 2 mg; 5 mg. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 55 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 52 24.2 Medicines used in mood disorders 24.2.1 Medicines used in depressive disorders amitriptyline Therapeutic alternatives to be reviewed (2023) Tablet: 25 mg; 75mg. (hydrochloride). fluoxetine Therapeutic alternatives: - citalopram - escitalopram - fluvoxamine - paroxetine - sertraline Solid oral dosage form: 20 mg (as hydrochloride). Complementary List fluoxetine a [c] Solid oral dosage form: 20 mg (as hydrochloride). a > 8 years. 24.2.2 Medicines used in bipolar disorders carbamazepine Tablet (scored): 100 mg; 200 mg. lithium carbonate Solid oral dosage form: 300 mg. valproic acid (sodium valproate)* *avoid use in pregnancy and in women and girls of child- bearing potential, unless alternative treatments are ineffective or not tolerated because of the high risk of birth defects and developmental disorders in children exposed to valproate in the womb. Tablet (enteric-coated): 200 mg; 500 mg. 24.3 Medicines for anxiety disorders diazepam Therapeutic alternatives to be reviewed (2023) Tablet (scored): 2 mg; 5 mg. 24.4 Medicines used for obsessive compulsive disorders clomipramine Capsule: 10 mg; 25 mg (hydrochloride). 24.5 Medicines for disorders due to psychoactive substance use bupropion Tablet (sustained-release): 150 mg (hydrochloride) nicotine replacement therapy (NRT) Chewing gum: 2 mg; 4 mg (as polacrilex). Transdermal patch: 5 mg to 30 mg/16 hrs; 7 mg to 21 mg/24 hrs. varenicline Tablet: 0.5 mg, 1 mg Complementary List methadone* Therapeutic alternatives: - buprenorphine Concentrate for oral liquid: 5 mg/mL; 10 mg/mL (hydrochloride). Oral liquid: 5 mg/5 mL; 10 mg/5 mL (hydrochloride). *The medicines should only be used within an established support programme. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 56 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 53 25. MEDICINES ACTING ON THE RESPIRATORY TRACT 25.1 Antiasthmatic medicines and medicines for chronic obstructive pulmonary disease budesonide Therapeutic alternatives: - beclometasone - ciclesonide - flunisolide - fluticasone - mometasone Inhalation (aerosol): 100 micrograms per dose; 200 micrograms per dose. budesonide + formoterol Therapeutic alternatives: - beclometasone + formoterol - budesonide + salmeterol - fluticasone + formoterol - fluticasone furoate + vilanterol - mometasone + formoterol Dry powder inhaler: 100 micrograms + 6 micrograms per dose; 200 micrograms + 6 micrograms per dose epinephrine (adrenaline) Injection: 1 mg/mL (as hydrochloride or hydrogen tartrate) in 1 mL ampoule. ipratropium bromide Inhalation (aerosol): 20 micrograms/metered dose. salbutamol Therapeutic alternatives: - terbutaline Inhalation (aerosol): 100 micrograms (as sulfate) per dose. Injection: 50 micrograms/mL (as sulfate) in 5 mL ampoule. Metered dose inhaler (aerosol): 100 micrograms (as sulfate) per dose. Respirator solution for use in nebulizers: 5 mg/mL (as sulfate). tiotropium Therapeutic alternatives: - aclidinium - glycopyrronium - umeclidinium Powder for inhalaton, capsule: 18 micrograms Inhalation solution: 1.25 micrograms; 2.5 micrograms per actuation 26. SOLUTIONS CORRECTING WATER, ELECTROLYTE AND ACID–BASE DISTURBANCES 26.1 Oral oral rehydration salts See section 17.5.1. potassium chloride Powder for solution. 26.2 Parenteral glucose Injectable solution: 5% (isotonic); 10% (hypertonic); 50% (hypertonic). glucose with sodium chloride Injectable solution: 4% glucose, 0.18% sodium chloride (equivalent to Na+ 30 mmol/L, Cl- 30 mmol/L). Injectable solution: 5% glucose, 0.9% sodium chloride (equivalent to Na+ 150 mmol/L and Cl- 150 mmol/L); 5% glucose, 0.45% sodium chloride (equivalent to Na+ 75 mmol/L and Cl- 75 mmol/L) [c]. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 57 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 54 potassium chloride Solution: 11.2% in 20 mL ampoule (equivalent to K+ 1.5 mmol/mL, Cl- 1.5 mmol/mL). Solution for dilution: 7.5% (equivalent to K 1 mmol/mL and Cl 1 mmol/mL) [c]; 15% (equivalent to K 2 mmol/mL and Cl 2 mmol/mL) [c]. sodium chloride Injectable solution: 0.9% isotonic (equivalent to Na+ 154 mmol/L, Cl- 154 mmol/L). sodium hydrogen carbonate Injectable solution: 1.4% isotonic (equivalent to Na+ 167 mmol/L, HCO3- 167 mmol/L). Solution: 8.4% in 10 mL ampoule (equivalent to Na+ 1000 mmol/L, HCO3-1000 mmol/L). sodium lactate, compound solution Injectable solution. 26.3 Miscellaneous water for injection 2 mL; 5 mL; 10 mL ampoules. 27. VITAMINS AND MINERALS ascorbic acid Tablet: 50 mg. calcium Tablet: 500 mg (elemental). colecalciferol [c] Therapeutic alternatives: - ergocalciferol Oral liquid: 400 IU/mL. Solid oral dosage form: 400 IU; 1000 IU. ergocalciferol Therapeutic alternatives: - colecalciferol Oral liquid: 250 micrograms/mL (10 000 IU/mL). Solid oral dosage form: 1.25 mg (50 000 IU). iodine Capsule: 190 mg. Iodized oil: 1 mL (480 mg iodine); 0.5 mL (240 mg iodine) in ampoule (oral or injectable); 0.57 mL (308 mg iodine) in dispenser bottle. multiple micronutrient powder [c] Sachets containing: - iron (elemental) 12.5 mg (as coated ferrous fumarate) - zinc (elemental) 5 mg - vitamin A 300 micrograms - with or without other micronutrients at recommended daily values nicotinamide Tablet: 50 mg. pyridoxine Tablet: 25 mg (hydrochloride). retinol Capsule: 50 000 IU; 100 000 IU; 200 000 IU (as palmitate). Oral oily solution: 100 000 IU/mL (as palmitate) in multidose dispenser. Tablet (sugar-coated): 10 000 IU (as palmitate). Water-miscible injection: 100 000 IU (as palmitate) in 2 mL ampoule. riboflavin Tablet: 5 mg. thiamine Tablet: 50 mg (hydrochloride). Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 58 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 55 Complementary List calcium gluconate Injection: 100 mg/mL in 10 mL ampoule. 28. EAR, NOSE AND THROAT MEDICINES acetic acid [c] Topical: 2%, in alcohol. budesonide [c] Therapeutic alternatives to be reviewed (2023) Nasal spray: 100 micrograms per dose. ciprofloxacin [c] Therapeutic alternatives: - ofloxacin Solution (ear drops): 0.3% (as hydrochloride). xylometazoline a [c] Therapeutic alternatives to be reviewed (2023) Nasal spray: 0.05%. a Not in children less than 3 months. 29. MEDICINES FOR DISEASES OF JOINTS 29.1 Medicines used to treat gout allopurinol Tablet: 100 mg. 29.2 Disease-modifying anti-rheumatic drugs (DMARDs) chloroquine Tablet: 100 mg; 150 mg (as phosphate or sulfate). Complementary List azathioprine Tablet: 50 mg. hydroxychloroquine Solid oral dosage form: 200 mg (as sulfate). methotrexate Tablet: 2.5 mg (as sodium salt). penicillamine Solid oral dosage form: 250 mg. sulfasalazine Tablet: 500 mg. 29.3 Juvenile joint diseases Complementary List acetylsalicylic acid* (acute or chronic use) Suppository: 50 mg to 150 mg. Tablet: 100 mg to 500 mg. *For use for rheumatic fever, juvenile arthritis, Kawasaki disease. 30. DENTAL PREPARATIONS fluoride Paste, cream or gel: containing between 1000 and 1500 ppm fluoride (any type). In other appropriate topical formulations. glass ionomer cement Single-use capsules: 0.4 g powder + 0.09 mL liquid. Multi-use bottle: powder + liquid. Powder (fluoro-alumino-silicate glass) contains: 25-50% silicate, 20-40% aluminium oxide, 1-20% fluoride, 15-40% metal oxide, 0-15% phosphate, remainder are polyacrylic acid powder and metals in minimal quantities. Liquid (aqueous) contains: 7-25% polybasic carboxylic acid, 45-60% polyacrylic acid. silver diamine fluoride Solution: 38% w/v. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 59 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 56 Table 1.1: Medicines with age or weight restrictions artesunate + pyronaridine tetraphosphate > 5 kg atropine > 3 months bedaquiline ≥ 5 years benzyl benzoate >2 years betamethasone topical preparations hydrocortisone preferred in neonates cefazolin > 1 month ceftriaxone > 41 weeks corrected gestational age darunavir > 3 years delamanid ≥ 3 years (25 mg dispersible tablet) ≥ 6 years (50 mg tablet) dihydroartemisinin + piperaquine phosphate > 5 kg diloxanide >25 kg dolutegravir ≥ 4 weeks and ≥ 3 kg (10 mg dispersible tablet) ≥ 25 kg (50 mg tablet) doxycycline > 8 years (except for serious infections e.g. cholera) fluoxetine > 8 years ibuprofen > 3 months (except IV form for patent ductus arteriosus) mefloquine > 5 kg or > 3 months metoclopramide Not in neonates nevirapine > 6 weeks ondansetron > 1 month silver sulfadiazine > 2 months tetracaine Not in preterm neonates xylometazoline > 3 months Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 60 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 57 Table 1.2: Explanation of dosage forms A. Principal dosage forms used in EML – oral administration Term Definition Solid oral dosage form Refers to tablets or capsules or other solid dosage forms such as 'melts' that are immediate-release preparations. It implies that there is no difference in clinical efficacy or safety between the available dosage forms, and countries should therefore choose the form(s) to be listed depending on quality and availability. The term 'solid oral dosage form' is never intended to allow any type of modified-release tablet. Tablets Refers to: • uncoated or coated (film-coated or sugar-coated) tablets that are intended to be swallowed whole; • unscored and scored*; • tablets that are intended to be chewed before being swallowed; • tablets that are intended to be dispersed or dissolved in water or another suitable liquid before being swallowed; • tablets that are intended to be crushed before being swallowed. The term 'tablet' without qualification is never intended to allow any type of modified-release tablet. Tablets (qualified) Refers to a specific type of tablet: chewable - tablets that are intended to be chewed before being swallowed; dispersible - tablets that are intended to be dispersed in water or another suitable liquid before being swallowed; soluble - tablets that are intended to be dissolved in water or another suitable liquid before being swallowed; crushable - tablets that are intended to be crushed before being swallowed; scored - tablets bearing a break mark or marks where sub-division is intended in order to provide doses of less than one tablet; sublingual - tablets that are intended to be placed beneath the tongue. The term 'tablet' is always qualified with an additional term (in parentheses) in entries where one of the following types of tablet is intended: gastro- resistant (such tablets may sometimes be described as enteric-coated or as delayed-release), prolonged-release or another modified-release form. * Scored tablets may be divided for ease of swallowing, provided that dose is a whole number of tablets. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 61 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 58 Capsules Refers to hard or soft capsules. The term 'capsule' without qualification is never intended to allow any type of modified-release capsule. Capsules (qualified) The term 'capsule' with qualification refers to gastro-resistant (such capsules may sometimes be described as enteric-coated or as delayed- release), prolonged-release or another modified-release form. Granules Preparations that are issued to patient as granules to be swallowed without further preparation, to be chewed, or to be taken in or with water or another suitable liquid. The term 'granules' without further qualification is never intended to allow any type of modified-release granules. Oral powder Preparations that are issued to patient as powder (usually as single-dose) to be taken in or with water or another suitable liquid. Oral liquid Liquid preparations intended to be swallowed i.e. oral solutions, suspensions, emulsions and oral drops, including those constituted from powders or granules, but not those preparations intended for oromucosal administration e.g. gargles and mouthwashes. Oral liquids presented as powders or granules may offer benefits in the form of better stability and lower transport costs. If more than one type of oral liquid is available on the same market (e.g. solution, suspension, granules for reconstitution), they may be interchanged and in such cases should be bioequivalent. It is preferable that oral liquids do not contain sugar and that solutions for children do not contain alcohol. B. Principal dosage forms used in EML – parenteral administration Term Definition Injection Refers to solutions, suspensions and emulsions including those constituted from powders or concentrated solutions. Injection (qualified) Route of administration is indicated in parentheses where relevant. Injection (oily) The term `injection’ is qualified by `(oily)’ in relevant entries. Intravenous infusion Refers to solutions and emulsions including those constituted from powders or concentrated solutions. C. Other dosage forms Mode of administration Term to be used To the eye Eye drops, eye ointments. Topical For liquids: lotions, paints. For semi-solids: cream, ointment. Rectal Suppositories, gel or solution. Vaginal Pessaries or vaginal tablets. Inhalation Powder for inhalation, pressurized inhalation, nebulizer. Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 62 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 59 Index abacavir 18 abacavir + lamivudine 19 abiraterone 31 acetazolamide 48 acetic acid 55 acetylcysteine 4 acetylsalicylic acid 2, 24, 38, 55 aciclovir 18, 47 adalimumab 25 albendazole 6 alcohol based hand rub 40 allopurinol 32, 55 all-trans retinoid acid (ATRA) 30 alteplase 38 amidotrizoate 40 amikacin 8, 16 amiloride 41 amiodarone 36 amitriptyline 3, 52 amlodipine 36 amodiaquine 21 amodiaquine – sulfadoxine + pyrimethamine 23 amoxicillin 8 amoxicillin + clavulanic acid 8, 16 amphotericin B 17, 21 ampicillin 9 anastrozole 31 anti-D immunoglobulin 34 anti-rabies immunoglobulin 34 anti-rabies virus monoclonal antibodies 45 anti-tetanus immunoglobulin 34 antivenom immunoglobulin 45 aprepitant 42 arsenic trioxide 25 artemether 21 artemether + lumefantrine 21 artesunate 22 artesunate + amodiaquine 22 artesunate + mefloquine 22 artesunate + pyronaridine tetraphosphate 22 ascorbic acid 54 asparaginase 25 atazanavir + ritonavir 18 atracurium 47 atropine 1, 4, 48 azathioprine 25, 55 azithromycin 12, 47 barium sulfate 40 BCG vaccine 46 bedaquiline 16 bendamustine 25 benzathine benzylpenicillin 9 benznidazole 24 benzoyl peroxide 39 benzyl benzoate 39 benzylpenicillin 9 betamethasone 39 bevacizumab 48 bicalutamide 31 biperiden 33 bisoprolol 35, 36, 37 bleomycin 25 bortezomib 30 budesonide 53, 55 budesonide + formoterol 53 bupivacaine 1 bupropion 52 caffeine citrate 50 calamine 39 calcipotriol 39 calcium 54 calcium folinate 25 calcium gluconate 4, 55 capecitabine 26 carbamazepine 5, 52 carbetocin 50 carboplatin 26 cefalexin 9 cefazolin 9 cefiderocol 14 cefixime 12 cefotaxime 12 ceftazidime 14 ceftazidime + avibactam 14 ceftriaxone 13 cefuroxime 13 charcoal, activated 4 chlorambucil 26 chloramphenicol 9 chlorhexidine 40, 50 chlorine base compound 40 chloroquine 22, 23, 55 chloroxylenol 41 chlorpromazine 51 cholera vaccine 46 ciclosporin 25 ciprofloxacin 13, 55 cisplatin 26 clarithromycin 13 clindamycin 10 clofazimine 15, 16 clomifene 49 clomipramine 52 clopidogrel 38 clotrimazole 17 cloxacillin 10 clozapine 51 coagulation factor IX 35 coagulation factor VIII 35 coal tar 39 codeine 2 colecalciferol 54 colistin 14 condoms 49 copper-containing device 49 cyclizine 3 cyclophosphamide 26 cycloserine 16 cytarabine 26 dabigatran 33 dacarbazine 27 daclatasvir 20 Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 63 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 60 daclatasvir + sofosbuvir 20 dactinomycin 27 dapsone 15 darunavir 18 dasabuvir 20 dasatinib 30 daunorubicin 27 deferoxamine 4, 34 delamanid 16 dengue vaccine 46 desmopressin 34 dexamethasone 3, 4, 31, 42, 50 dextran 70 35 diaphragms 49 diazepam 3, 5, 52 diazoxide 44 diethylcarbamazine 6 digoxin 35, 37 dihydroartemisinin + piperaquine phosphate 22 diloxanide 21 dimercaprol 4 diphtheria antitoxin 45 diphtheria vaccine 46 docetaxel 27 docusate sodium 3 dolutegravir 19 dolutegravir + lamivudine + tenofovir 19 dopamine 38 doxorubicin 27 doxycycline 10, 22, 23 efavirenz 18 efavirenz + emtricitabine + tenofovir 19 efavirenz + lamivudine + tenofovir 19 eflornithine 24 empagliflozin 44 emtricitabine + tenofovir 19 enalapril 36, 37 enoxaparin 33 entecavir 20 ephedrine 1 epinephrine (adrenaline) 4, 35, 48, 53 equine rabies immunoglobulin 45 ergocalciferol 54 ergometrine 50 erlotinib 30 erythromycin 47 erythropoiesis-stimulating agents 33 estradiol cypionate + medroxyprogesterone acetate 49 ethambutol 15 ethambutol + isoniazid + pyrazinamide + rifampicin 15 ethambutol + isoniazid + rifampicin 15 ethanol 40 ethinylestradiol + etonogestrel 49 ethinylestradiol + levonorgestrel 49 ethinylestradiol + norethisterone 49 ethionamide 16 ethosuximide 6 etonogestrel-releasing implant 49 etoposide 27 everolimus 30 fentanyl 2 ferrous salt 33 ferrous salt + folic acid 33 fexinidazole 23 filgrastim 31 fluconazole 17 flucytosine 17 fludarabine 27 fludrocortisone 43 fluorescein 40 fluoride 55 fluorouracil 28, 39 fluoxetine 3, 52 fluphenazine 51 folic acid 33 fomepizole 4 fosfomycin 14 fresh-frozen plasma 34 furosemide 37, 41 gemcitabine 28 gentamicin 10, 47 glass ionomer cement 55 glecaprevir + pibrentasvir 20 gliclazide 44 glucagon 44 glucose 53 glucose with sodium chloride 53 glutaral 41 glyceryl trinitrate 35 griseofulvin 17 Haemophilus influenzae type b vaccine 46 haloperidol 3, 51 halothane 1 heparin sodium 33, 34 hepatitis A vaccine 46 hepatitis B vaccine 46 human papilloma virus (HPV) vaccine 46 hydralazine 36 hydrochlorothiazide 36, 37, 41 hydrocortisone 4, 31, 39, 42, 43 hydroxocobalamin 33 hydroxycarbamide 28, 34 hydroxychloroquine 55 hyoscine butylbromide 3 hyoscine hydrobromide 3 ibrutinib 30 ibuprofen 2, 24, 51 ifosfamide 28 imatinib 30 influenza vaccine 47 insulin injection (soluble) 44 intermediate-acting insulin 44 intraperitoneal dialysis solution (of appropriate composition) 51 iodine 54 iohexol 40 ipratropium bromide 53 irinotecan 28 isoflurane 1 isoniazid 15 isoniazid + pyrazinamide + rifampicin 15 isoniazid + pyridoxine + sulfamethoxazole + trimethoprim 19 isoniazid + rifampicin 15 isoniazid + rifapentine 15 isosorbide dinitrate 35 itraconazole 17 ivermectin 6, 24 Japanese encephalitis vaccine 46 ketamine 1 Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 64 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 61 lactulose 3 lamivudine 18 lamivudine + zidovudine 19 lamotrigine 5 latanoprost 48 ledipasvir + sofosbuvir 20 lenalidomide 31 leuprorelin 32 levamisole 6 levodopa + carbidopa 33 levofloxacin 16 levonorgestrel 49 levonorgestrel-releasing implant 49 levonorgestrel-releasing intrauterine system 49 levothyroxine 44 lidocaine 1, 35 lidocaine + epinephrine (adrenaline) 1 linezolid 14, 16 lisinopril + amlodipine 36 lisinopril + hydrochlorothiazide 36 lithium carbonate 52 long-acting insulin analogues 44 loperamide 3 lopinavir + ritonavir 18 loratadine 4 lorazepam 5 losartan 36, 37 Lugol's solution 45 magnesium sulfate 5 mannitol 41 measles vaccine 46 mebendazole 6 medroxyprogesterone acetate 43, 49 mefloquine 22, 23 meglumine antimoniate 21 meglumine iotroxate 40 melarsoprol 24 melphalan 28 meningococcal meningitis vaccine 46 mercaptopurine 28 meropenem 14, 16 meropenem + vaborbactam 14 mesna 32 metformin 44 methadone 2, 52 methimazole 44, 45 methotrexate 28, 55 methyldopa 37 methylprednisolone 32 methylthioninium chloride (methylene blue) 4 metoclopramide 3, 42 metronidazole 11, 21 micafungin 17 miconazole 38 midazolam 1, 3, 5 mifepristone – misoprostol 50 miltefosine 21 misoprostol 50 morphine 1, 2 moxifloxacin 15, 16 multiple micronutrient powder 54 multiple micronutrient supplement 50 mumps vaccine 47 mupirocin 39 naloxone 4 natamycin 48 neostigmine 47 nevirapine 18 niclosamide 6 nicotinamide 54 nicotine replacement therapy (NRT) 52 nifedipine 50 nifurtimox 24 nilotinib 30 nitrofurantoin 11 nitrous oxide 1 nivolumab 31 norethisterone enantate 49 normal immunoglobulin 35 nystatin 17 ofloxacin 48 ombitasvir + paritaprevir + ritonavir 20 omeprazole 41 ondansetron 3, 42 oral rehydration salts 43, 53 oral rehydration salts – zinc sulfate 42 oseltamivir 20 oxaliplatin 28 oxamniquine 6 oxygen 1, 2 oxytocin 50 paclitaxel 29 paliperidone 51 p-aminosalicylic acid 16 pancreatic enzymes 41 paracetamol 2, 24 paromomycin 21 pegaspargase 29 pegylated interferon alfa 2a 21 penicillamine 4, 55 pentamidine 23 permethrin 39 pertussis vaccine 46 phenobarbital 5 phenoxymethylpenicillin 11 phenytoin 5 phytomenadione 33 pilocarpine 48 piperacillin + tazobactam 14 platelets 34 plazomicin 14 pneumococcal vaccine 46 podophyllum resin 39 poliomyelitis vaccine 46 polymyxin B 14 potassium chloride 53, 54 potassium ferric hexacyano-ferrate(II) -2H20 (Prussian blue) 4 potassium iodide 17, 44, 45 potassium permanganate 39 povidone iodine 40 praziquantel 6 prednisolone 4, 32, 42, 48 primaquine 22 procaine benzylpenicillin 11 procarbazine 29 progesterone vaginal ring 49 proguanil 23 propofol 1 propranolol 24 Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 65 of 67 WHO Model List of Essential Medicines – 22nd List (2021) WHO Model List of Essential Medicines – 22nd List (2021) page 62 propylthiouracil 44, 45 prostaglandin E1 51 protamine sulfate 33 pyrantel 6 pyrazinamide 15 pyridostigmine 47 pyridoxine 54 pyrimethamine 23 quinine 22 rabies vaccine 47 raltegravir 19 ranitidine 41 rasburicase 32 realgar-Indigo naturalis formulation 29 red blood cells 34 retinol 54 ribavirin 19, 21 riboflavin 54 rifabutin 15 rifampicin 15 rifapentine 15 risperidone 51 ritonavir 18 rituximab 30 rotavirus vaccine 46 rubella vaccine 46 salbutamol 53 salicylic acid 39 selenium sulfide 38 senna 3, 42 silver diamine fluoride 55 silver sulfadiazine 39 simvastatin 38 sodium calcium edetate 4 sodium chloride 54 sodium hydrogen carbonate 54 sodium lactate 54 sodium nitrite 4 sodium nitroprusside 37 sodium stibogluconate 21 sodium thiosulfate 4, 38 sofosbuvir 20 sofosbuvir + velpatasvir 20 spectinomycin 11 spironolactone 38, 41 streptokinase 38 streptomycin 16 succimer 4 sulfadiazine 23 sulfadoxine + pyrimethamine 22, 23 sulfamethoxazole + trimethoprim 11, 23 sulfasalazine 42, 55 sumatriptan 24 suramin sodium 23 surfactant 51 suxamethonium 47 tacrolimus 25 tamoxifen 32 telmisartan + amlodipine 37 telmisartan + hydrochlorothiazide 37 tenofovir disoproxil fumarate 18, 20 terbinafine 38 testosterone 43 tetanus vaccine 46 tetracaine 48 tetracycline 48 thalidomide 31 thiamine 54 tick-borne encephalitis vaccine 46 timolol 48 tioguanine 29 tiotropium 53 tranexamic acid 34, 50 trastuzumab 30 triclabendazole 6 trimethoprim 12 tropicamide 40 tuberculin, purified protein derivative (PPD) 45 typhoid vaccine 47 ulipristal 49 urea 39 valganciclovir 19, 20 valproic acid (sodium valproate) 5, 6, 52 vancomycin 14 varenicline 52 varicella vaccine 47 vecuronium 47 verapamil 35 vinblastine 29 vincristine 29 vinorelbine 29 voriconazole 17 warfarin 34 water for injection 54 whole blood 34 xylometazoline 55 yellow fever vaccine 46 zidovudine 18 zinc sulfate 43 zoledronic acid 32 Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 66 of 67 Case 3:22-cv-00184 Document 12-13 Filed on 08/08/22 in TXSD Page 67 of 67
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