ISBN 9789240041134 W H O T e c h n i c a l R e p o r t S e r i e s 1035 Report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2021 (including the 22nd WHO Model List of Essen.
1035 Annexes to the main report include the WHO Model List of Essential Medicines – 22nd list (2021), the WHO Model List of Essential Medicines for Children – 8th list (2021), and the list of all essential medicines with Anatomical Therapeutic Chemical (ATC) classification codes The Selection and Use of Essential Medicines This report presents the recommendations of the WHO Expert Committee responsible for updating the Who Model List of Essential Medicines and WHO Model List of Essential Medicines for Children It contains a summary of the evidence presented and the Committee’s consideration, justifications and recommendations for additions, deletions and changes to medicines on the Model Lists WHO Technical Report Series ISBN 9789240041134 W H O Te c h n i c a l R e p o r t S e r i e s 1035 The Selection and Use of Essential Medicines Report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2021 (including the 22nd WHO Model List of Essential Medicines and the 8th WHO Model List of Essential Medicines for Children) SELECTED WHO PUBLICATIONS OF RELATED INTEREST The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health One of WHO’s constitutional functions is to provide objective and reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world To respond to the needs of Member States at all levels of development, WHO publishes practical manuals, handbooks and training material for specific categories of health workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and research; and 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medicines: report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2021 (including the 22nd WHO Model List of Essential Medicines and the 8th WHO Model List of Essential Medicines for Children) (WHO Technical Report Series, No 1035) ISBN 978-92-4-004113-4 (electronic version) ISBN 978-92-4-004114-1 (print version) ISSN 0512-3054 © World Health Organization 2021 Some rights reserved This work is available under the Creative Commons Attribution-NonCommercialShareAlike 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 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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 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 Layout by Interligar Contents Executive summary vii List of participants xli Declaration of interests for Expert Committee members and temporary advisers xliv Introduction Open session 3 General items Summary of recommendations Applications for the 22nd Model List of Essential Medicines and the 8th Model List of Essential Medicines for Children 13 20 Section 4: ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS 20 4.2 Specific 20 N-acetylcysteine – addition – EML and EMLc 20 Section 5: ANTICONVULSANTS/ANTIEPILEPTICS 28 Valproic acid (sodium valproate) – change to listing – EML and EMLc 28 Section 6: ANTI-INFECTIVE MEDICINES 33 6.1 Anthelminthics 33 Albendazole, mebendazole, praziquantel – new indication – EML and EMLc 33 6.2 Antibacterials 43 Antibiotics for bronchitis and bronchiolitis – new indication – EML and EMLc 43 Antibiotics for ocular infections – new indications – EML and EMLc 48 Antibiotics for necrotizing fasciitis – new indication – EML and EMLc 56 Antibiotics for neonatal meningitis – new indication – EMLc 61 Antibiotics for intra-abdominal infections in children – new indication – EMLc 67 Amoxicillin – remove indication – EML and EMLc 71 Amoxicillin + clavulanic acid – new formulation – EML 74 Cefalexin – change indication – EML and EMLc 81 Ceftazidime + avibactam – addition - EML 84 Antibiotics – new formulations – EML 95 Moxifloxacin and rifapentine – new indication – EML 99 Pyrazinamide – new formulation – EML and EMLc 104 Rifapentine – new formulation – EML and EMLc 108 Rifapentine + isoniazid – new formulation – EML and EMLc 117 Antituberculosis medicines – formulations for deletion – EML and EMLc 124 Antituberculosis medicines – new formulations – EML and EMLc 129 Bedaquiline – new formulation – EML and EMLc 135 Delamanid – new formulation – EMLc 141 6.3 Antifungal medicines 148 Echinocandin antifungals – addition – EML and EMLc 148 6.4 Antiviral medicines 165 Antiretrovirals – formulations for deletion – EML and EMLc 165 Dolutegravir – new formulation – EMLc Abacavir + lamivudine + lopinavir/ritonavir – new formulation – EMLc Oseltamivir – deletion – EML and EMLc Glecaprevir + pibrentasvir – addition – EMLc Daclatasvir and sofosbuvir – addition – EMLc Sofosbuvir + velpatasvir – addition – EMLc Section 7: ANTIMIGRAINE MEDICINES 7.1 For treatment of acute attack Sumatriptan – addition – EML Section 8: IMMUNOMODULATORS AND ANTINEOPLASTICS 8.1 Immunomodulators for non-malignant disease Tacrolimus – addition – EML and EMLc 8.2 Antineoplastics and supportive medicines Azacitidine – addition – EML Cancer medicines for low-grade glioma – new indication – EML and EMLc Cancer medicines for children – new indications – EML and EMLc Cancer medicines for head and neck cancer – review – EML Doxorubicin for rhabdomyosarcoma – review – EML and EMLc Vinorelbine – new indication – EML and EMLc BRAF/MEK inhibitors – addition – EML Cyclin-dependent kinase (CDK) 4/6 inhibitors – addition – EML Everolimus – addition – EML and EMLc Ibrutinib – addition – EML Imatinib – new indication – EML Osimertinib – addition – EML Pertuzumab – addition – EML Zanubrutinib – addition for chronic lymphocytic leukaemia/small lymphocytic lymphoma – EML Zanubrutinib – addition for mantle cell lymphoma – EML PD-1/PD-L1 immune checkpoint inhibitors – addition – EML Daratumumab – addition – EML Tislelizumab – addition for Hodgkin lymphoma – EML Tislelizumab – addition for urothelial cancer – EML Enzalutamide – addition – EML Fulvestrant – addition – EML Rasburicase – addition – EML and EMLc CAR-T cell therapy – review Section 13: DERMATOLOGICAL MEDICINES 13.4 Medicines affecting skin differentiation and proliferation Calcipotriol – addition – EML and EMLc Section 15: DISINFECTANTS AND ANTISEPTICS 15.1 Antiseptics 15.2 Disinfectants Hypochlorous acid – addition – EML and EMLc Section 18: MEDICINES FOR ENDOCRINE DISORDERS Simvastatin – new indication – EML 18.5 Medicines for diabetes Long-acting insulin analogues – addition – EML and EMLc iv 169 178 185 189 196 205 212 212 212 221 221 221 236 236 242 248 255 262 267 272 283 296 303 312 320 328 340 347 353 376 388 394 401 412 419 427 442 442 442 451 451 451 451 461 461 470 470 Sodium-glucose cotransporter-2 (SGLT2) inhibitors – addition – EML Section 19: IMMUNOLOGICALS 19.2 Sera, immunoglobulins and monoclonal antibodies Anti-rabies virus monoclonal antibodies – addition – EML and EMLc Equine rabies immunoglobulin – addition – EML and EMLc Section 22: MEDICINES FOR REPRODUCTIVE HEALTH AND PERINATAL CARE 22.1 Contraceptives Ethinylestradiol + etonogestrel – new formulation – EML 22.5 Other medicines administered to the mother Multiple micronutrient supplement – addition – EML Section 24: MEDICINES FOR MENTAL AND BEHAVIOURAL DISORDERS Methylphenidate – addition – EML and EMLc 24.1 Medicines used in psychotic disorders Paliperidone and risperidone long-acting injection – addition – EML 24.5 Medicines for disorders due to psychoactive substance use Bupropion – addition – EML Varenicline – addition – EML Section 29: MEDICINES FOR DISEASES OF JOINTS 29.2 Disease-modifying anti-rheumatic drugs (DMARDs) Hydroxychloroquine – new indication – EML 29.3 Juvenile joint diseases Anakinra – addition – EML and EMLc Tocilizumab – addition – EML and EMLc Triamcinolone – addition – EML and EMLc Section 30: DENTAL PREPARATIONS Fluoride toothpaste – addition – EML and EMLc Glass ionomer cement – addition – EML and EMLc Silver diamine fluoride – addition – EML and EMLc 486 499 499 499 507 513 513 513 520 520 532 532 543 543 555 555 578 601 601 601 609 609 619 632 640 640 651 660 Annex WHO Model List of Essential Medicines – 22nd List (2021) 667 Annex WHO Model List of Essential Medicines for Children – 8th List (2021) 755 Annex Alphabetical list of essential medicines (with ATC codes & section numbers) 813 v Executive summary The meeting of the 23rd WHO Expert Committee on the Selection and Use of Essential Medicines took place virtually and was hosted in Geneva, Switzerland, from 21 June to July 2021 The aim of the meeting was to review and update the 21st WHO Model List of Essential Medicines (EML) and the 7th WHO Model List of Essential Medicines for Children (EMLc), the Model Lists The Expert Committee considered a total of 88 applications, including 40 proposals for the addition of 38 new medicines or medicine classes, 16 proposals for new indications for 32 currently listed medicines, 13 proposals for the addition of new formulations of 19 currently listed medicines, and three proposals for the removal of 19 medicines or formulations on the Model Lists In accordance with applicable procedures 1, the Expert Committee evaluated the scientific evidence for the comparative effectiveness, safety and cost–effectiveness of the medicines in question The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists (square box listings), an update to the AWaRe (Access–Watch– Reserve) classification of antibiotics to support stewardship activities, a review of the available evidence for CAR-T cell therapies for B-cell lymphoma, and reports on insulin pricing and access, and switching between originator and similar biotherapeutic products (biosimilars) The Expert Committee did not consider any applications for the inclusion of medicines for the treatment or prevention of coronavirus disease 2019 (COVID-19) The COVID-19 pandemic has seen the quick evolution of knowledge on a previously unknown disease, rapidly evolving clinical hypotheses and proposals of potential treatments As knowledge accumulates within an emergency framework for a pathogen that is rapidly evolving, the quality of the evidence necessarily also changes over short time frames This scenario does not fit within the intended aim of the EML, which has a longer-term scope and gives much weight to the certainty of the value of selected medicines In the emergency context, WHO recommendations on bestavailable treatments are presented as part of WHO guidelines However, this scenario might evolve and therapeutic options for COVID-19 may be considered for inclusion in Model Lists in the future In summary, the Expert Committee: ■■ recommended the addition of 20 new medicines to the EML (13 to the core list and seven to the complementary list); ■■ recommended the addition of 17 new medicines to the EMLc (12 to the core list and five to the complementary list); ■■ recommended adding additional indications for 28 currently listed medicines; ■■ recommended the addition of new formulations of 23 currently listed medicines; ■■ recommended the deletion of two medicines and of specific formulations of a further 13 medicines; http://www.who.int/selection_medicines/committees/subcommittee/2/eeb1098%5b1%5d.pdf vii The Selection and Use of Essential Medicines Report of the 23rd WHO Expert Committee ■■ updated 72 square box listings, removed the square box from seven listings, and recommended a review of a further 23 square box listings; and ■■ did not recommend 25 proposals for inclusion, change or deletion for 28 medicines, medicine classes or formulations The recommended changes bring the total number of medicines (including fixed-dose combinations) on the EML to 479 (from 460 in 2019), including 350 on the EMLc (from 336 in 2019) The total number of listed medicines takes into account the additions and deletions, as well as changes made as a result of the revision of therapeutic equivalent alternatives The recommendations are briefly described below in order of their appearance on the Model Lists A full summary of changes to the Model Lists is shown in Table Applications not recommended are shown in Table Section 4: Antidotes and other substances used in poisonings Section 4.2 Specific The Expert Committee did not recommend listing for N-acetylcysteine for the new indication of non-paracetamol-induced acute liver failure based on very low certainty of the available evidence and heterogeneity in the results, making confidence in the estimates of benefit in this indication limited WHO Technical Report Series, No 1035, 2021 Section 5: Anticonvulsants/antiepileptics viii The Expert Committee recommended the inclusion of a cautionary note with the listings for valproic acid (sodium valproate) on the EML and EMLc, to avoid use in pregnancy and in females of child-bearing potential, unless alternative treatments are ineffective or not tolerated, due to the high risk of birth defects and developmental disorders in children exposed to valproate in the womb The Committee did not recommend transferring the listings of valproic acid from the core to the complementary list due to concerns that doing so may reduce access and undermine the important role of this medicine in the management of epilepsy and bipolar disorder This recommendation also applies to the listing on the EML for valproic acid in Section 24.2.2 Medicines used in bipolar disorders Section 6: Anti-infective medicines Section 6.1.4 (NEW) Cysticidal medicines The Expert Committee recommended inclusion of albendazole, mebendazole and praziquantel on the complementary list of the EML and EMLc for the new indication of treatment of diseases caused by taeniid cestode infections Albendazole and mebendazole are recommended for treatment of cystic echinococcosis and alveolar echinococcosis; albendazole and praziquantel are recommended for treatment of neurocysticercosis The Committee noted that these medicines are considered treatments of choice for these neglected tropical diseases and are recommended in current WHO guidelines Annex 3: Alphabetical list of essential medicines (with ATC codes & section numbers) Medicine or item as in EML ATC code Section copper-containing device G02BA02 22.1.3 cyclizine R06AE03 2.3 cyclophosphamide L01AA01 8.2.1 cycloserine J04AB01 6.2.5 cytarabine L01BC01 8.2.1 dabigatran B01AE07 10.2 dacarbazine L01AX04 8.2.1 daclatasvir J05AP07 6.4.4.2.1 daclatasvir + sofosbuvir J05AP07 J05AP08 6.4.4.2.1 dactinomycin L01DA01 8.2.1 dapsone J04BA02 6.2.4 darbepoetin alfa B03XA02 10.1 darunavir J05AE10 6.4.2.3 dasabuvir J05AP09 6.4.4.2.2 dasatinib L01EA02 8.2.2 daunorubicin L01DB02 8.2.1 deferoxamine V03AC01 4.2; 10.3 delamanid J04AK06 6.2.5 dengue vaccine – 19.3 desmopressin H01BA02 10.2 dexamethasone H02AB02 2.3; 3; 8.2.4; 17.2; 22.5 dextran 70 B05AA05 11.3 diaphrams – 22.1.4 diazepam N05BA01 2.3; 5; 24.3 diazoxide V03AH01 18.6 diethylcarbamazine P02CB02 6.1.2 digoxin C01AA05 12.2; 12.4 dihydroartemisinin + piperaquine phopshate P01BF05 6.5.3.1 diloxanide P01AC01 6.5.1 dimercaprol V03AB09 4.2 817 WHO Technical Report Series, No 1035, 2021 The Selection and Use of Essential Medicines Report of the 23rd WHO Expert Committee 818 Medicine or item as in EML ATC code Section diphtheria antitoxin J06AA01 19.2 diphtheria vaccine J07AF01 19.3 docetaxel L01CD02 8.2.1 docusate sodium A06AA02 2.3 dolutegravir J05AJ03 6.4.2.4 dolutegravir + lamivudine + tenofovir J05AR27 6.4.2.5 dopamine C01CA04 12.4 doxorubicin L01DB01 8.2.1 doxycycline J01AA02 6.2.1; 6.5.3.1; 6.5.3.2 efavirenz J05AG03 6.4.2.2 efavirenz + emtricitabine + tenofovir disoproxil J05AR06 6.4.2.5 efavirenz + lamivudine + tenofovir disoproxil J05AR11 6.4.2.5 eflornithine P01CX03 6.5.5.1 empagliflozin A10BK03 18.5.2 emtricitabine + tenofovir disoproxil J05AR03 6.4.2.5 enalapril C09AA02 12.3; 12.4 enoxaparin B01AB05 10.2 entecavir J05AF10 6.4.4.1.1 ephedrine C01CA26 1.2 epinephrine S01EA01 21.5 epinephrine (adrenaline) C01CA24 3; 12.2; 25.1 equine rabies immunoglobulin J06BB05 19.2 ergocalciferol A11CC01 27 ergometrine G02AB03 22.3 erlotinib L01EB02 8.2.2 erythromycin S01AA17 21.1 erythropoiesis-stimulating agents B03XA01 B03XA02 B03XA03 10.1 estradiol cypionate + medroxyprogesterone acetate G03AA17 22.1.2 Annex 3: Alphabetical list of essential medicines (with ATC codes & section numbers) Medicine or item as in EML ATC code Section ethambutol J04AK02 6.2.5 ethambutol + isoniazid + pyrazinamide + rifampicin J04AM06 6.2.5 ethambutol + isoniazid + rifampicin J04AM07 6.2.5 ethanol D08AX08 15.1 ethinylestradiol + etonogestrel G02BB01 22.1.6 ethinylestradiol + levonorgestrel G03AA07 22.1.1 ethinylestradiol + norethisterone G03AA05 22.1.1 ethionamide J04AD03 6.2.5 ethosuximide N03AD01 etonogestrel- releasing implant G03AC08 22.1.5 etoposide L01CB01 8.2.1 everolimus L01EG02 8.2.2 fentanyl N02AB03 2.2 ferrous salt B03AA02 B03AA07 10.1 ferrous salt + folic acid B03AD02 B03AD03 10.1 fexinidazole P01CA03 6.5.5.1 filgrastim L03AA02 8.2.3 fluconazole J02AC01 6.3 flucytosine J02AX01 6.3 fludarabine L01BB05 8.2.1 fludrocortisone H02AA02 18.1 fluorescein S01JA01 14.1 fluoride A01AA 30 fluorouracil L01BC02 8.2.1; 13.4 fluoxetine N06AB03 2.3; 24.2.1 fluphenazine N05AB02 24.1 folic acid B03BB01 10.1 fomepizole V03AB34 4.2 fosfomycin J01XX01 6.2.3 819 WHO Technical Report Series, No 1035, 2021 The Selection and Use of Essential Medicines Report of the 23rd WHO Expert Committee 820 Medicine or item as in EML ATC code Section fresh frozen plasma B05AX03 11.1 furosemide C03CA01 12.4; 16 gemcitabine L01BC05 8.2.1 gentamicin J01GB03 6.2.1 gentamicin S01AA11 21.1 glass ionomer cement – 30 glecaprevir + pibrentasvir J05AP57 6.4.4.2.1 gliclazide A10BB09 18.5.2 glucagon H04AA01 18.6 glucose B05CX01 26.2 glucose with sodium chloride B05BA03 26.2 glutaral – 15.2 glyceryl trinitrate C01DA02 12.1 griseofulvin D01BA01 6.3 Haemophilus influenzae type b vaccine J07AG01 19.3 haloperidol N05AD01 2.3; 24.1 halothane N01AB01 1.1.1 heparin sodium B01AB01 10.2 hepatitis A vaccine J07BC02 19.3 hepatitis B vaccine J07BC01 19.3 hydralazine C02DB02 12.3 hydrochlorothiazide C03AA03 12.3; 12.4; 16 hydrocortisone A07EA02 17.3 hydrocortisone D07AA02 13.3 hydrocortisone H02AB09 3; 8.2.4; 18.1 hydroxocobalamin B03BA03 10.1 hydroxycarbamide L01XX05 8.2.1; 10.3 hydroxychloroquine P01BA02 29.2 hyoscine butylbromide A03BB01 2.3 hyoscine hydrobromide A04AD01 2.3 Annex 3: Alphabetical list of essential medicines (with ATC codes & section numbers) Medicine or item as in EML ATC code Section ibrutinib L01EL01 8.2.2 ibuprofen C01EB16 22.6 ibuprofen M01AE01 2.1; 7.1 ifosfamide L01AA06 8.2.1 imatinib L01EA01 8.2.2 influenza vaccine J07BB 19.3 insulin injection (soluble) (human) A10AB01 18.5.1 Intermediate-acting insulin (human) A10AC01 18.5.1 intraperitoneal dialysis solution – 23 iodine H03CA 18.7; 27 iodine D08AG03 6.3 iohexol V08AB02 14.2 ipratropium bromide R03BB01 25.1 irinotecan L01CE02 8.2.1 isoflurane N01AB06 1.1.1 isoniazid J04AC01 6.2.5 isoniazid + pyrazinamide + rifampicin J04AM05 6.2.5 isoniazid + pyridoxine + sulfamethoxazole + trimethoprim J04AM08 6.4.2.6 isoniazid + rifampicin J04AM02 6.2.5 isoniazid + rifapentine J04AC51 6.2.5 isosorbide dinitrate C01DA08 12.1 itraconazole J02AC02 6.3 ivermectin P02CF01 6.1.1; 6.1.2; 6.6 Japanese encephalitis vaccine J07BA02 J07BA03 19.3 ketamine N01AX03 1.1.2 lactulose A06AD11 2.3 lamivudine J05AF05 6.4.2.1 lamivudine + zidovudine J05AR01 6.4.2.5 821 WHO Technical Report Series, No 1035, 2021 The Selection and Use of Essential Medicines Report of the 23rd WHO Expert Committee 822 Medicine or item as in EML ATC code Section lamotrigine N03AX09 latanoprost S01EE01 21.4 ledipasvir + sofosbuvir J05AP51 6.4.4.2.2 lenalidomide L04AX04 8.2.3 leuprorelin L02AE02 8.2.4 levamisole P02CE01 6.1.1 levodopa + carbidopa N04BA02 levofloxacin J01MA12 6.2.5 levonorgestrel G03AC03 22.2.1 levonorgestrel G03AD01 22.2.1 levonorgestrel-releasing implant G03AC03 22.1.5 levonorgestrel-releasing intrauterine system G02BA03 22.1.3 levothyroxine H03AA01 18.7 lidocaine C01BB01 12.2 lidocaine N01BB02 1.2 lidocaine + epinephrine N01BB52 1.2 linezolid J01XX08 6.2.3; 6.2.5 lisinopril + amlodipine C09BB03 12.3 lisinopril + hydrochlorothiazide C09BA03 12.3 lithium carbonate N05AN01 24.2.2 long-acting insulin analogues A10AE04 A10AE05 A10AE06 18.5.1 loperamide A07DA03 2.3 lopinavir + ritonavir J05AR10 6.4.2.3 loratadine R06AX13 lorazepam N05BA06 losartan C09CA01 12.3; 12.4 Lugol’s solution H03CA 18.7 magnesium sulfate B05XA05 mannitol B05BC01 16 Annex 3: Alphabetical list of essential medicines (with ATC codes & section numbers) Medicine or item as in EML ATC code Section measles vaccine J07BD01 19.3 mebendazole P02CA01 6.1.1; 6.1.4 medroxyprogesterone acetate G03AC06 22.1.2 medroxyprogesterone acetate G03DA02 18.4 mefloquine P01BC02 6.5.3.1; 6.5.3.2 meglumine antimoniate P01CB01 6.5.2 meglumine iotroxate V08AC02 14.2 melarsoprol P01CD01 6.5.5.1 melphalan L01AA03 8.2.1 meningococcal meningitis vaccine J07AH 19.3 mercaptopurine L01BB02 8.2.1 meropenem J01DH02 6.2.2; 6.2.5 meropenem + vaborbactam J01DH52 6.2.3 mesna V03AF01 8.2.5 metformin A10BA02 18.5.2 methadone N07BC02 2.2; 24.5 methimazole H03BB02 18.7 methotrexate L01BA01 8.2.1 methotrexate L04AX03 29.2 methyldopa C02AB01 12.3 methylprednisolone H02AB04 8.2.4 methylthioninium chloride (methylene blue) V03AB17 4.2 metoclopramide A03FA01 2.3; 17.2 metronidazole J01XD01 6.2.1 metronidazole P01AB01 6.5.1 micafungin J02AX05 6.3 miconazole D01AC02 13.1 midazolam N05CD08 1.3; 2.3; mifepristone – misoprostol G03XB01 G02AD06 22.3 miltefosine P01CX04 6.5.2 misoprostol G02AD06 22.3 823 WHO Technical Report Series, No 1035, 2021 The Selection and Use of Essential Medicines Report of the 23rd WHO Expert Committee 824 Medicine or item as in EML ATC code Section morphine N02AA01 1.3; 2.2 moxifloxacin J01MA14 6.2.5 multiple micronutrient powder A11AA01 27 multiple micronutrient supplement A11AA01 22.5 mumps vaccine J07BE01 19.3 mupirocin D06AX09 13.2 naloxone V03AB15 4.2 natamycin S01AA10 21.1 neostigmine N07AA01 20 nevirapine J05AG01 6.4.2.2 niclosamide P02DA01 6.1.1 nicotinamide A11HA01 27 nicotine replacement therapy N07BA01 24.5 nifedipine C08CA05 22.4 nifurtimox P01CC01 6.5.5.1; 6.5.5.2 nilotinib L01EA03 8.2.2 nitrofurantoin J01XE01 6.2.1 nitrous oxide N01AX13 1.1.1 nivolumab L01FF01 8.2.3 norethisterone enantate G03AC01 22.1.2 normal immunoglobulin J06BA 11.2.1 nystatin A07AA02 G01AA01 6.3 ofloxacin S01AE01 21.1 ombitasvir + paritaprevir + ritonavir J05AP53 6.4.4.2.2 omeprazole A02BC01 17.1 ondansetron A04AA01 2.3; 17.2 oral rehydration salts A07CA 17.5.1; 26.1 oral rehydration salts – zinc sulfate A07CA A12CB01 17.5 oseltamivir J05AH02 6.4.3 Annex 3: Alphabetical list of essential medicines (with ATC codes & section numbers) Medicine or item as in EML ATC code Section oxaliplatin L01XA03 8.2.1 oxamniquine P02BA02 6.1.3 oxygen V03AN01 1.1.1; 1.4 oxytocin H01BB02 22.3 paclitaxel L01CD01 8.2.1 p-aminosalicylic acid J04AA01 6.2.5 pancreatic enzymes A09AA02 17 paracetamol N02BE01 2.1; 7.1 paromomycin A07AA06 6.5.2 pegaspargase L01XX24 8.2.1 pegylated interferon alfa (2a or 2b) L03AB10 L03AB11 6.4.4.2.3 penicillamine M01CC01 4.2; 29.2 pentamidine P01CX01 6.5.4; 6.5.5.1 permethrin P03AC04 13.5 pertussis vaccine J07AJ01 19.3 phenobarbital N03AA02 phenoxymethylpenicillin J01CE02 6.2.1 phenytoin N03AB02 phytomenadione B02BA01 10.2 pilocarpine S01EB01 21.4 piperacillin + tazobactam J01CR05 6.2.2 platelets B05A 11.1 plazomicin J01GB14 6.2.3 pneumococcal vaccine J07AL01 19.3 podophyllum resin 13.4 poliomyelitis vaccine J07BF 19.3 polymyxin B J01XB02 6.2.3 potassium chloride B05XA01 26.1; 26.2 potassium ferric hexacyanoferrate (II) ·2H O (Prussian blue) potassium iodide V03AB31 4.2 D08AG03 6.3 825 WHO Technical Report Series, No 1035, 2021 The Selection and Use of Essential Medicines Report of the 23rd WHO Expert Committee 826 Medicine or item as in EML ATC code Section potassium iodide V03AB21 18.7 potassium permanganate D08AX06 13.2 povidone iodine D08AG02 15.1 praziquantel P02BA01 6.1.1; 6.1.3; 6.1.4 prednisolone H02AB06 3; 8.2.4 prednisolone S01BA04 21.2 primaquine P01BA03 6.5.3.1 procaine benzylpenicillin J01CE09 6.2.1 procarbazine L01XB01 8.2.1 progesterone vaginal ring G02BB02 22.1.6 proguanil P01BB01 6.5.3.2 propofol N01AX10 1.1.2 propranolol C07AA05 7.2 propylthiouracil H03BA02 18.7 prostaglandin E1 C01EA 22.6 protamine sulfate V03AB14 10.2 pyrantel P02CC01 6.1.1 pyrazinamide J04AK01 6.2.5 pyridostigmine N07AA02 20 pyridoxine A11HA02 27 pyrimethamine P01BD01 6.5.4 quinine P01BC01 6.5.3.1 rabies vaccine J07BG 19.3 raltegravir J05AJ01 6.4.2.4 ranitidine A02BA02 17.1 rasburicase V03AF07 8.2.5 realgar-Indigo naturalis formula – 8.2.1 red blood cells B05AX01 11.1 retinol A11CA01 27 ribavirin J05AP01 6.4.3; 6.4.4.2.3 riboflavin A11HA04 27 Annex 3: Alphabetical list of essential medicines (with ATC codes & section numbers) Medicine or item as in EML ATC code Section rifabutin J04AB04 6.2.5 rifampicin J04AB02 6.2.4; 6.2.5 rifapentine J04AB05 6.2.5 risperidone N05AX08 24.1 ritonavir J05AE03 6.4.2.3 rituximab L01FA01 8.2.2 rotavirus vaccines J07BH 19.3 rubella vaccines J07BJ 19.3 salbutamol R03AC02 25.1 salicylic acid D01AE12 13.4 selenium sulfide D01AE13 13.1 senna A06AB06 2.3; 17.4 silver diamine fluoride – 30 silver sulfadiazine D06BA01 13.2 simvastatin C10AA01 12.6 sodium calcium edetate V03AB03 4.2 sodium chloride B05XA03 26.2 sodium hydrogen carbonate B05XA02 26.2 sodium lactate compound solution – 26.2 sodium nitrite V03AB08 4.2 sodium nitroprusside C02DD01 12.3 sodium stibogluconate P01CB02 6.5.2 sodium thiosulfate V03AB06 4.2; 13.1 sofosbuvir J05AP08 6.4.4.2.1 sofosbuvir + velpatasvir J05AP55 6.4.4.2.1 spectinomycin J01XX04 6.2.1 spironolactone C03DA01 12.4; 16 streptokinase B01AD01 12.5.2 streptomycin J01GA01 6.2.5 succimer – 4.2 sulfadiazine J01EC02 6.5.4 sulfadoxine + pyrimethamine P01BD51 6.5.3.1 827 WHO Technical Report Series, No 1035, 2021 The Selection and Use of Essential Medicines Report of the 23rd WHO Expert Committee 828 Medicine or item as in EML ATC code Section sulfamethoxazole + trimethoprim J01EE01 6.2.1; 6.5.4 sulfasalazine A07EC01 17.3; 29.2 sumatriptan N02CC01 7.1 suramin sodium P01CX02 6.5.5.1 suxamethonium M03AB01 20 tacrolimus L04AD02 8.1 tamoxifen L02BA01 8.2.4 telmisartan + amlodipine C09DB04 12.3 telmisartan + hydrochlorothiazide C09DA07 12.3 tenofovir disoproxil fumarate J05AF07 6.4.2.1; 6.4.4.1.1 terbinafine D01AE15 13.1 testosterone G03BA03 18.2 tetanus vaccine J07AM01 19.3 tetracaine S01HA03 21.3 tetracycline S01AA09 21.1 thalidomide L04AX02 8.2.3 thiamine A11DA01 27 tick-borne encephalitis vaccine J07BA01 19.3 timolol S01ED01 21.4 tioguanine L01BB03 8.2.1 tiotropium R03BB04 25.1 tranexamic acid B02AA02 10.2; 22.5 trastuzumab L01FD01 8.2.2 triclabendazole P02BX04 6.1.3 trimethoprim J01EA01 6.2.1 tropicamide S01FA06 14.1 tuberculin, purified protein derivative (PPD) V04CF01 19.1 typhoid vaccine J07AP 19.3 ulipristal G03AD02 22.1.1 urea D02AE01 13.4 Annex 3: Alphabetical list of essential medicines (with ATC codes & section numbers) Medicine or item as in EML ATC code Section valganciclovir J05AB14 6.4.3 valproic acid (sodium valproate) N03AG01 5; 24.2.2 vancomycin J01XA01 A07AA09 6.2.2 varenicline N07BA03 24.5 varicella vaccines J07BK 19.3 vecuronium M03AC03 20 verapamil C08DA01 12.1; 12.2 vinblastine L01CA01 8.2.1 vincristine L01CA02 8.2.1 vinorelbine L01CA04 8.2.1 voriconazole J02AC03 6.3 warfarin B01AA03 10.2 water for Injection V07AB 26.3 whole blood B05A 11.1 xylometazoline R01AA07 28 yellow fever vaccine J07BL01 19.3 zidovudine J05AF01 6.4.2.1 zinc sulfate A12CB01 17.5.2 zoledronic acid M05BA08 8.2.5 829 SELECTED WHO PUBLICATIONS OF RELATED INTEREST The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health One of WHO’s constitutional functions is to provide objective and reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world To respond to the needs of Member States at all levels of development, WHO publishes practical manuals, handbooks and training material for specific 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100-year-old promise: making insulin access universal (2021) ISBN 9789240039100 Technical report: pricing of cancer medicines and its impacts: a comprehensive technical report for the World Health Assembly Resolution 700.12: operative paragraph 2.9 on pricing approaches and their impacts on availability of medicines for the prevention and treatment of cancer (2018) ISBN 9789241515115 mhGAP intervention guide for mental, neurological and substance use disorders in non-specialized health settings: mental health Gap Action Programme (mhGAP) – version 2.0 (2016) ISBN 978924154979 Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach (2021) ISBN 9789240031593 WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - DrugResistant Tuberculosis Treatment (2020) ISBN 9789240007048 Guidelines on second- and third-line medicines and type of insulin for the control of blood glucose levels in 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presents the recommendations of the WHO Expert Committee responsible for updating the Who Model List of Essential Medicines and WHO Model List of Essential Medicines for Children It contains a summary of the evidence presented and the Committee’s consideration, justifications and recommendations for additions, deletions and changes to medicines on the Model Lists WHO Technical Report Series ISBN 9789240041134 W H O Te c h n i c a l R e p o r t S e r i e s 1035 The Selection and Use of Essential Medicines Report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2021 (including the 22nd WHO Model List of Essential Medicines and the 8th WHO Model List of Essential Medicines for Children)