WHO Model List
`of
`Essential Medicines
`
`
`
`19th List
`(April 2015)
`(Amended November 2015)
`
`Status of this document
`
`
`This is a reprint of the text on the WHO Medicines website
`
`http://www.who.int/medicines/publications/essentialmedicines/en/
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`MYLAN - EXHIBIT 1043
`Mylan et al. v. AstraZeneca
`IPR2015-01340
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`

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`The published material is being distributed without warrant 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 the
`World Health Organization be liable for damages arising from its use.
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`19th edition
`
`WHO Model List of Essential Medicines (April 2015)
`
`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.
`
`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.
`
`The square box symbol () is primarily intended to indicate similar clinical performance within a
`pharmacological class. The listed medicine should be the example of the class 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 boxes are
`applicable to medicine selection for children — see the second EMLc for details.
`
`Therapeutic equivalence is indicated only on the basis of reviews of efficacy and safety and when consistent
`with WHO clinical guidelines. 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.
`
`Where the [c] symbol is placed next to 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.
`
`Where the [c] symbol is placed next to an individual medicine or strength of medicine it signifies that there
`is a specific indication for restricting its use to children.
`
`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
`Medicines website http://www.who.int/medicines/areas/quality_assurance.
`
`Medicines and dosage forms are listed in alphabetical order within each section and there is no implication
`of 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
`http://www.who.int/medicines/publications/pharmacopoeia.
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`Essential Medicines
`WHO Model List
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`1. ANAESTHETICS
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`19th edition
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`1.1 General anaesthetics and oxygen
`
`1.1.1 Inhalational medicines
`
`halothane
`
`isoflurane
`
`nitrous oxide
`
`oxygen
`
`1.1.2 Injectable medicines
`
`ketamine
`
`propofol*
`
`1.2 Local anaesthetics
`
` bupivacaine
`
` lidocaine
`
`lidocaine + epinephrine (adrenaline)
`
`Complementary List
`
`ephedrine
`
`Inhalation.
`
`Inhalation.
`
`Inhalation.
`
`Inhalation (medicinal gas).
`
`Injection: 50 mg (as hydrochloride)/ mL in 10- mL vial.
`
`Injection: 10 mg/ mL; 20 mg/ mL.
`
`* Thiopental may be used as an alternative depending on local
`availability and cost.
`
`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.
`
`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).
`
`Dental cartridge: 2% (hydrochloride) + epinephrine 1:80 000.
`
`Injection: 1%; 2% (hydrochloride or sulfate) + epinephrine
`1:200 000 in vial.
`
`Injection: 30 mg (hydrochloride)/ mL 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
`
`Oral liquid: 2 mg/ mL [c].
`
`Tablet: 7.5 mg; 15 mg.
`
`Injection: 1 mg/ mL.
`
`morphine
`
`Injection: 10 mg (sulfate or hydrochloride) in 1- mL ampoule.
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`2. MEDICINES FOR PAIN AND PALLIATIVE CARE
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`19th edition
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`2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs)
`
`acetylsalicylic acid
`
`ibuprofen a
`
`paracetamol*
`
`Suppository: 50 mg to 150 mg.
`
`Tablet: 100 mg to 500 mg.
`
`Oral liquid: 200 mg/5 mL.
`
`Tablet: 200 mg; 400 mg; 600 mg.
`
`a Not in children less than 3 months.
`
`Oral liquid: 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).
`
` morphine*
`
`Granules (slow-release; to mix with water): 20 mg –
`200 mg (morphine sulfate).
`
`Injection: 10 mg (morphine hydrochloride or
`morphine sulfate) in 1- mL ampoule.
`
`Oral liquid: 10 mg (morphine hydrochloride or
`morphine sulfate)/5 mL.
`
`Tablet (slow release): 10 mg–200mg (morphine
`hydrochloride or morphine sulfate).
`
`Tablet (immediate release): 10 mg (morphine
`sulfate).
`
`*Alternatives limited to hydromorphone and
`oxycodone
`
`2.3 Medicines for other common symptoms in palliative care
`
`amitriptyline
`
`cyclizine [c]
`
`dexamethasone
`
`Tablet: 10 mg; 25 mg; 75 mg.
`
`Injection: 50 mg/ mL.
`
`Tablet: 50 mg.
`
`Injection: 4 mg/ mL in 1- mL ampoule (as disodium
`phosphate salt).
`
`Oral liquid: 2 mg/5 mL.
`
`Tablet: 2 mg [c]; 4 mg.
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`diazepam
`
`docusate sodium
`
`fluoxetine a
`
`Injection: 5 mg/ mL.
`
`Oral liquid: 2 mg/5 mL.
`
`Rectal solution: 2.5 mg; 5 mg; 10 mg.
`
`Tablet: 5 mg; 10 mg.
`
`Capsule: 100 mg.
`
`Oral liquid: 50 mg/5 mL.
`
`Solid oral dosage form: 20 mg (as hydrochloride).
`
`a >8 years.
`
`Injection: 5 mg in 1‐ mL ampoule.
`
`haloperidol
`
`Oral liquid: 2 mg/ mL.
`
`Solid oral dosage form: 0.5 mg; 2mg; 5 mg.
`
`hyoscine butylbromide
`
`Injection: 20 mg/ mL.
`
`hyoscine hydrobromide [c]
`
`lactulose [c]
`
`loperamide
`
`metoclopramide
`
`Injection: 400 micrograms/ mL; 600 micrograms/
`mL.
`
`Transdermal patches: 1 mg/72 hours.
`
`Oral liquid: 3.1–3.7 g/5 mL.
`
`Solid oral dosage form: 2 mg.
`
`Injection: 5 mg (hydrochloride)/mL in 2‐mL
`ampoule.
`
`Oral liquid: 5 mg/5 mL.
`
`Solid oral form: 10 mg (hydrochloride).
`
`Injection: 1 mg/ mL; 5 mg/ mL.
`
`midazolam
`
`Solid oral dosage form: 7.5 mg; 15 mg.
`
`Oral liquid: 2mg/ mL [c].
`
`Injection: 2 mg base/ mL in 2- mL ampoule (as
`hydrochloride).
`
`ondansetron [c] a
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`Oral liquid: 4 mg base/5 mL.
`
`senna
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`Solid oral dosage form: Eq 4 mg base; Eq 8 mg base.
`
`a >1 month.
`
`Oral liquid: 7.5 mg/5 mL.
`
`3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS
`
`dexamethasone
`
`epinephrine (adrenaline)
`
`hydrocortisone
`
`Injection: 4 mg/ mL in 1- mL ampoule (as disodium
`phosphate salt).
`
`Injection: 1 mg (as hydrochloride or hydrogen
`tartrate) in 1- mL ampoule.
`
`Powder for injection: 100 mg (as sodium succinate)
`in vial.
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` loratadine *
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`
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` prednisolone
`
`Oral liquid: 1 mg/ mL.
`
`Tablet: 10 mg.
`
`*There may be a role for sedating antihistamines for
`limited indications (EMLc).
`
`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
`
`4.2 Specific
`
`acetylcysteine
`
`atropine
`
`calcium gluconate
`
`methylthioninium chloride
`(methylene blue)
`
`naloxone
`
`penicillamine
`
`potassium ferric hexacyano-ferrate(II) -
`2H2O(Prussian blue)
`
`sodium nitrite
`
`sodium thiosulfate
`
`Complementary List
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`deferoxamine
`
`dimercaprol
`
`fomepizole
`
`Powder.
`
`Injection: 200 mg/ mL in 10- mL ampoule.
`
`Oral liquid: 10% [c]; 20% [c].
`
`Injection: 1 mg (sulfate) in 1- mL ampoule.
`
`Injection: 100 mg/ mL in 10- mL ampoule.
`
`Injection: 10 mg/ mL in 10- mL ampoule.
`
`Injection: 400 micrograms (hydrochloride) in 1- mL
`ampoule.
`
`Solid oral dosage form: 250 mg.
`
`Powder for oral administration.
`
`Injection: 30 mg/ mL in 10- mL ampoule.
`
`Injection: 250 mg/ mL in 50- mL ampoule.
`
`Powder for injection: 500 mg (mesilate) in vial.
`
`Injection in oil: 50 mg/ mL in 2- mL ampoule.
`
`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.
`
`
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`5. ANTICONVULSANTS/ANTIEPILEPTICS
`
`19th edition
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`carbamazepine
`
`Tablet (chewable): 100 mg; 200 mg.
`
`Oral liquid: 100 mg/5 mL.
`
`diazepam
`
` lorazepam
`
`magnesium sulfate*
`
`
`
`midazolam
`
`phenobarbital
`
`phenytoin
`
`valproic acid (sodium valproate)
`
`Complementary List
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`ethosuximide
`
`Tablet (scored): 100 mg; 200 mg.
`
`Gel or rectal solution: 5 mg/ mL in 0.5 mL; 2- mL; 4-
`mL tubes.
`
`Parenteral formulation: 2 mg/ mL in 1- mL
`ampoule; 4 mg/ mL in 1- mL ampoule.
`
`Injection: 0.5g/ mL in 2- mL ampoule (equivalent to
`1 g in 2 mL; 50% weight/volume); 0.5g/ 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.
`
`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
`
`Injection: 200 mg/ mL (sodium).
`
`Oral liquid: 15 mg/5 mL.
`
`Tablet: 15 mg to 100 mg.
`
`Injection: 50 mg/ mL in 5- mL vial (sodium salt).
`
`Oral liquid: 25 mg to 30 mg/5 mL.*
`
`Solid oral dosage form: 25 mg; 50 mg; 100 mg
`(sodium salt).
`
`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.
`
`Oral liquid: 200 mg/5 mL.
`
`Tablet (crushable): 100 mg.
`
`Tablet (enteric-coated): 200 mg; 500 mg (sodium
`valproate).
`
`Capsule: 250 mg.
`
`Oral liquid: 250 mg/5 mL.
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`valproic acid (sodium valproate)
`
`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
`
`levamisole
`
`mebendazole
`
`niclosamide
`
`praziquantel
`
`pyrantel
`
`6.1.2 Antifilarials
`
`albendazole
`
`diethylcarbamazine
`
`ivermectin
`
`Tablet (chewable): 400 mg.
`
`Tablet: 50 mg; 150 mg (as hydrochloride).
`
`Tablet (chewable): 100 mg; 500 mg.
`
`Tablet (chewable): 500 mg.
`
`Tablet: 150 mg; 600 mg.
`
`Oral liquid: 50 mg (as embonate or pamoate)/ mL.
`
`Tablet (chewable): 250 mg (as embonate or
`pamoate).
`
`Tablet (chewable): 400 mg.
`
`Tablet: 50 mg; 100 mg (dihydrogen citrate).
`
`Tablet (scored): 3 mg.
`
`6.1.3 Antischistosomals and other antitrematode medicines
`
`praziquantel
`
`triclabendazole
`
`Complementary List
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`oxamniquine*
`
`6.2 Antibacterials
`
`6.2.1 Beta-lactam medicines
`
`amoxicillin
`
`amoxicillin + clavulanic acid
`
`Tablet: 600 mg.
`
`Tablet: 250 mg.
`
`Capsule: 250 mg.
`
`Oral liquid: 250 mg/5 mL.
`
`* Oxamniquine is listed for use when praziquantel
`treatment fails.
`
`Powder for oral liquid: 125 mg (as trihydrate)/5
`mL; 250 mg (as trihydrate)/5 mL [c].
`
`Solid oral dosage form: 250 mg; 500 mg (as
`trihydrate).
`
`Oral liquid: 125 mg amoxicillin + 31.25 mg
`clavulanic acid/5 mL AND 250 mg amoxicillin +
`62.5 mg clavulanic acid/5 mL [c].
`
`Tablet: 500 mg (as trihydrate) + 125 mg (as
`potassium salt).
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`Essential Medicines
`WHO Model List
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`ampicillin
`
`benzathine benzylpenicillin
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`benzylpenicillin
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`cefalexin [c]
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`Powder for injection: 500 mg; 1 g (as sodium salt) in
`vial.
`
`Powder for injection: 900 mg benzylpenicillin
`(= 1.2 million IU) in 5- mL vial [c]; 1.44 g
`benzylpenicillin (= 2.4 million IU) in 5- mL vial.
`
`Powder for injection: 600 mg (= 1 million IU); 3 g (=
`5 million IU) (sodium or potassium salt) in vial.
`
`Powder for reconstitution with water: 125 mg/5
`mL; 250 mg/5 mL (anhydrous).
`
`Solid oral dosage form: 250 mg (as monohydrate).
`
`Powder for injection: 1 g (as sodium salt) in vial.
`
` cefazolin* a
`
`* For surgical prophylaxis.
`
`cefixime*
`
`ceftriaxone* a
`
` cloxacillin
`
`phenoxymethylpenicillin
`
`procaine benzylpenicillin*
`
`Complementary List
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`cefotaxime* [c]
`
`a >1 month.
`
`Capsule: 400 mg (as trihydrate).
`
`* Listed only for single-dose treatment of
`uncomplicated anogenital gonorrhoea.
`
`Powder for injection: 250 mg; 1 g (as sodium salt) in
`vial.
`
`* Do not administer with calcium and avoid in
`infants with hyperbilirubinaemia.
`
`a >41 weeks corrected gestational age.
`
`Capsule: 500 mg; 1 g (as sodium salt).
`
`Powder for injection: 500 mg (as sodium salt) in
`vial.
`
`Powder for oral liquid: 125 mg (as sodium
`salt)/5 mL.
`
`Powder for oral liquid: 250 mg (as potassium
`salt)/5 mL.
`
`Tablet: 250 mg (as potassium salt).
`
`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.
`
`Powder for injection: 250 mg per vial (as sodium salt).
`
`* 3rd generation cephalosporin of choice for use in
`hospitalized neonates.
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`WHO Model List
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`ceftazidime
`
`imipenem* + cilastatin*
`
`6.2.2 Other antibacterials
`
`azithromycin*
`
`chloramphenicol
`
` ciprofloxacin*
`
`clarithromycin*
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`doxycycline a
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`19th edition
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`Powder for injection: 250 mg or 1 g (as pentahydrate)
`in vial.
`
`Powder for injection: 250 mg (as monohydrate) +
`250 mg (as sodium salt); 500 mg (as monohydrate) +
`500 mg (as sodium salt) in vial.
`
`* Listed only for the treatment of life-threatening hospital-
`based infection due to suspected or proven multidrug-
`resistant infection.
`
`Meropenem is indicated for the treatment of meningitis
`and is licensed for use in children over the age of 3
`months.
`
`Capsule: 250 mg; 500 mg (anhydrous).
`
`Oral liquid: 200 mg/5 mL.
`
`* Only listed for single-dose treatment of genital
`Chlamydia trachomatis and of trachoma.
`
`Capsule: 250 mg.
`
`Oily suspension for injection*: 0.5 g (as sodium
`succinate)/ mL in 2- mL ampoule.
`
`* Only for the presumptive treatment of epidemic
`meningitis in children older than 2 years.
`
`Oral liquid: 150 mg (as palmitate)/5 mL.
`
`Powder for injection: 1 g (sodium succinate) in vial.
`
`Oral liquid: 250 mg/5 mL (anhydrous) [c].
`
`Solution for IV infusion: 2 mg/ mL (as hyclate) [c].
`
`Tablet: 250 mg (as hydrochloride).
`
`* Square box applies to adults only.
`
`Solid oral dosage form: 500 mg.
`
`* For use in combination regimens for eradication of
`H. Pylori in adults.
`
`Oral liquid: 25 mg/5 mL [c]; 50 mg/5 mL
`(anhydrous) [c].
`
`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.
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` erythromycin
`
` gentamicin
`
` metronidazole
`
`nitrofurantoin
`
`spectinomycin
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`sulfamethoxazole + trimethoprim
`
`trimethoprim a
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`Complementary List
`
`Powder for injection: 500 mg (as lactobionate) in
`vial.
`
`Powder for oral liquid: 125 mg/5 mL (as stearate or
`estolate or ethyl succinate).
`
`Solid oral dosage form: 250 mg (as stearate or
`estolate or ethyl succinate).
`
`Injection: 10 mg; 40 mg (as sulfate)/ mL in 2- mL
`vial.
`
`Injection: 500 mg in 100- mL vial.
`
`Oral liquid: 200 mg (as benzoate)/5 mL.
`
`Suppository: 500 mg; 1 g.
`
`Tablet: 200 mg to 500 mg.
`
`Oral liquid: 25 mg/5 mL [c].
`
`Tablet: 100 mg.
`
`Powder for injection: 2 g (as hydrochloride) in vial.
`
`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.
`
`Oral liquid: 50 mg/5 mL [c].
`
`Tablet: 100 mg; 200 mg.
`
`a >6 months.
`
`Capsule: 150 mg (as hydrochloride).
`
`clindamycin
`
`Injection: 150 mg (as phosphate)/ mL.
`
`Oral liquid: 75 mg/5 mL (as palmitate) [c].
`
`vancomycin
`
`Powder for injection: 250 mg (as hydrochloride) in vial.
`
`6.2.3 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
`
`dapsone
`
`Capsule: 50 mg; 100 mg.
`
`Tablet: 25 mg; 50 mg; 100 mg.
`
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`rifampicin
`
`Solid oral dosage form: 150 mg; 300 mg.
`
`6.2.4 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 to 400 mg (hydrochloride).
`
`ethambutol + isoniazid
`
`Tablet: 400 mg + 150 mg.
`
`ethambutol + isoniazid + pyrazinamide +
`rifampicin
`
`Tablet: 275 mg + 75 mg + 400 mg + 150 mg.
`
`ethambutol + isoniazid + rifampicin
`
`Tablet: 275 mg + 75 mg + 150 mg.
`
`isoniazid
`
`isoniazid + pyrazinamide + rifampicin
`
`isoniazid + rifampicin
`
`pyrazinamide
`
`rifabutin
`
`rifampicin
`
`rifapentine*
`
`streptomycin
`
`Complementary List
`
`Oral liquid: 50 mg/5 mL [c].
`
`Tablet: 100 mg to 300 mg.
`
`Tablet (scored): 50 mg.
`
`Tablet:
`
`75 mg + 400 mg + 150 mg.
`150 mg + 500 mg + 150 mg (For intermittent use
`three times weekly).
`
`Tablet:
`
`75 mg + 150 mg; 150 mg + 300 mg.
`60 mg + 60 mg (For intermittent use three times
`weekly).
`150 mg + 150 mg (For intermittent use three times
`weekly).
`
`Oral liquid: 30 mg/ mL [c].
`
`Tablet: 400 mg.
`
`Tablet (dispersible): 150 mg.
`
`Tablet (scored): 150 mg.
`
`Capsule: 150 mg.*
`
`* For use only in patients with HIV receiving
`protease inhibitors.
`
`Oral liquid: 20 mg/ mL [c].
`
`Solid oral dosage form: 150 mg; 300 mg.
`
`Tablet: 150 mg
`
`*For treatment of latent TB infection (LTBI) only
`
`Powder for injection: 1 g (as sulfate) in vial.
`
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`Reserve second-line drugs for the treatment of multidrug-resistant tuberculosis (MDR-TB) should
`be used in specialized centres adhering to WHO standards for TB control.
`
`amikacin
`
`bedaquiline
`
`capreomycin
`
`cycloserine*
`
`delamanid
`
`ethionamide*
`
`kanamycin
`
`levofloxacin*
`
`linezolid
`
`p-aminosalicylic acid
`
`Powder for injection: 100 mg; 500 mg; 1 g (as sulfate)
`in vial.
`
`Tablet: 100 mg
`
`Powder for injection: 1 g (as sulfate) in vial.
`
`Solid oral dosage form: 250 mg.
`
`*Terizidone may be an alternative
`
`Tablet: 50 mg
`
`Tablet: 125 mg; 250 mg.
`
`*Protionamide may be an alternative.
`
`Powder for injection: 1 g (as sulfate) in vial.
`
`Tablet: 250mg; 500 mg; 750 mg.
`
`* Ofloxacin and moxifloxacin may be alternatives based
`on availability and programme considerations.
`
`Injection for intravenous administration: 2 mg/ mL
`in 300 mL bag
`
`Powder for oral liquid: 100 mg/5 mL,
`
`Tablet: 400 mg; 600 mg
`
`Granules: 4 g in sachet.
`
`Tablet: 500 mg.
`
`streptomycin [c]
`
`Powder for injection: 1 g (as sulfate) in vial.
`
`6.3 Antifungal medicines
`
`amphotericin B
`
`clotrimazole
`
` fluconazole
`
`flucytosine
`
`griseofulvin
`
`Powder for injection: 50 mg in vial (as sodium
`deoxycholate or liposomal complex).
`
`Vaginal cream: 1%; 10%.
`
`Vaginal tablet: 100 mg; 500 mg.
`
`Capsule: 50 mg.
`
`Injection: 2 mg/ mL in vial.
`
`Oral liquid: 50 mg/5 mL.
`
`Capsule: 250 mg.
`
`Infusion: 2.5 g in 250 mL.
`
`Oral liquid: 125 mg/5 mL [c].
`
`Solid oral dosage form: 125 mg; 250 mg.
`
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`nystatin
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`Complementary List
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`potassium iodide
`
`6.4 Antiviral medicines
`
`6.4.1 Antiherpes medicines
`
` aciclovir
`
`6.4.2 Antiretrovirals
`
`
`
`
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`Lozenge: 100 000 IU.
`
`19th edition
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`Oral liquid: 50 mg/5 mL [c]; 100 000 IU/ mL [c].
`
`Pessary: 100 000 IU.
`
`Tablet: 100 000 IU; 500 000 IU.
`
`Saturated solution.
`
`Oral liquid: 200 mg/5 mL [c].
`
`Powder for injection: 250 mg (as sodium salt) in
`vial.
`
`Tablet: 200 mg.
`
`Based on current evidence and experience of use, medicines in the following three classes of
`antiretrovirals are included as essential medicines for treatment and prevention of HIV (prevention of
`mother-to-child transmission 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 (ABC)
`
`lamivudine (3TC)
`
`stavudine (d4T)
`
`Oral liquid: 100 mg (as sulfate)/5 mL.
`
`Tablet: 300 mg (as sulfate).
`
`Oral liquid: 50 mg/5 mL.
`
`Tablet: 150 mg.
`
`Capsule: 15 mg; 20 mg; 30 mg.
`
`Powder for oral liquid: 5 mg/5 mL.
`
`tenofovir disoproxil fumarate (TDF)
`
`Tablet: 300 mg (tenofovir disoproxil fumarate –
`equivalent to 245 mg tenofovir disoproxil).
`
`zidovudine (ZDV or AZT)
`
`Capsule: 100 mg; 250 mg.
`
`Oral liquid: 50 mg/5 mL.
`
`Solution for IV infusion injection: 10 mg/ mL in
`20- mL vial.
`
`Tablet: 300 mg.
`
`6.4.2.2 Non-nucleoside reverse transcriptase inhibitors
`
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`efavirenz (EFV or EFZ) a
`
`Tablet: 200 mg (scored); 600 mg.
`
`Capsule: 50 mg; 100 mg; 200 mg.
`
`nevirapine (NVP)
`
`6.4.2.3 Protease inhibitors
`
`a >3 years or >10 kg weight.
`
`Oral liquid: 50 mg/5 mL.
`
`Tablet: 50 mg (dispersible); 200 mg.
`
`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 a
`
`darunavir a
`
`lopinavir + ritonavir (LPV/r)
`
`ritonavir
`
`saquinavir (SQV) a
`
`FIXED-DOSE COMBINATIONS
`
`abacavir + lamivudine
`
`efavirenz + emtricitabine* + tenofovir
`
`emtricitabine* + tenofovir
`
`Solid oral dosage form: 100 mg; 150 mg; 300 mg (as
`sulfate).
`
`a >25 kg.
`
`Tablet: 75 mg; 400 mg; 600 mg; 800 mg
`
`a >3 years
`
`Oral liquid: 400 mg + 100 mg/5 mL.
`
`Tablet (heat stable): 100 mg + 25 mg;
`200 mg + 50 mg.
`
`Oral liquid: 400 mg/5 mL.
`
`Tablet (heat stable): 25 mg; 100 mg.
`
`Solid oral dosage form: 200 mg; 500 mg (as
`mesilate).
`
`a >25 kg.
`
`Tablet (dispersible, scored): 60 mg (as sulfate) + 30
`mg
`
`Tablet: 600 mg + 200 mg + 300 mg (disoproxil
`fumarate equivalent to 245 mg tenofovir disoproxil).
`
`*Emtricitabine (FTC) is an acceptable alternative to
`3TC, based on knowledge of the pharmacology, the
`resistance patterns and clinical trials of
`antiretrovirals.
`
`Tablet: 200 mg + 300 mg (disoproxil fumarate
`equivalent to 245 mg tenofovir disoproxil).
`
`*Emtricitabine (FTC) is an acceptable alternative to
`3TC, based on knowledge of the pharmacology, the
`resistance patterns and clinical trials of
`antiretrovirals.
`
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`lamivudine + nevirapine + stavudine
`
`lamivudine + nevirapine + zidovudine
`
`Tablet: 150 mg + 200 mg + 30 mg.
`
`Tablet (dispersible): 30 mg + 50 mg + 6 mg [c].
`
`Tablet: 30 mg + 50 mg + 60 mg [c]; 150 mg + 200 mg
`+ 300 mg.
`
`lamivudine + zidovudine
`
`Tablet: 30 mg + 60 mg [c]; 150 mg + 300 mg.
`
`6.4.3 Other antivirals
`
`oseltamivir*
`
`ribavirin*
`
`Capsule: 30 mg; 45 mg; 75 mg (as phosphate).
`
`Oral powder: 12 mg/ mL.
`
`* potentially severe or complicated illness due to
`confirmed or suspected influenza virus infection in
`accordance with WHO treatment guidelines.
`
`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).
`
`
`
`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 (TDF)
`
`Tablet: 300 mg (tenofovir disoproxil fumarate –
`equivalent to 245 mg tenofovir disoproxil).
`
`6.4.4.2 Medicines for hepatitis C
`
`
`
`Based on current evidence, medicines in the following classes of direct acting antiviral medicines are
`included as essential medicines for treatment of hepatitis C virus infection. WHO guidelines recommend
`specific combination therapy utilizing medicines from different classes.
`
`6.4.4.2.1 Nucleotide polymerase inhibitors
`
`sofosbuvir
`
`Tablet: 400 mg
`
`6.4.4.2.2 Protease inhibitors
`
`simeprevir
`
`Capsule 150 mg
`
`6.4.4.2.3 NS5A inhibitors
`
`daclatasvir
`
`Tablet: 30 mg; 60 mg (as hydrochloride)
`
`6.4.4.2.4 Non-nucleoside polymerase inhibitors
`
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`dasabuvir
`
`Tablet: 250 mg
`
`6.4.4.2.5 Other antivirals
`
`19th edition
`
`ribavirin*
`
`Complementary List
`
`pegylated interferon alfa (2a or 2b) *
`
`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 peginterferon and/or direct acting anti-viral
`medicines
`
`Vial or prefilled syringe:
`
`180 micrograms (peginterferon alfa-2a),
`
`80 microgram, 100 microgram (peginterferon alfa-2b).
`
`* To be used in combination with ribavirin.
`
`FIXED-DOSE COMBINATIONS
`
`Alternative combinations of DAAs from different pharmacological classes are possible
`
`ledipasvir + sofosbuvir
`
`Tablet: 90 mg + 400 mg.
`
`ombitasvir + paritaprevir + ritonavir
`
`Tablet: 12.5 mg + 75 mg + 50 mg
`
`6.5 Antiprotozoal medicines
`
`6.5.1 Antiamoebic and antigiardiasis medicines
`
`diloxanide a
`
`Tablet: 500 mg (furoate).
`
`a >25 kg.
`
`Injection: 500 mg in 100- mL vial.
`
` metronidazole
`
`Oral liquid: 200 mg (as benzoate)/5 mL.
`
`Tablet: 200 mg to 500 mg.
`
`6.5.2 Antileishmaniasis medicines
`
`amphotericin B
`
`miltefosine
`
`paromomycin
`
`sodium stibogluconate or meglumine antimoniate
`
`6.5.3 Antimalarial medicines
`
`6.5.3.1 For curative treatment
`
`Powder for injection: 50 mg in vial (as sodium
`deoxycholate or liposomal complex).
`
`Solid oral dosage form: 10 mg; 50 mg.
`
`Solution for intramuscular injection: 750 mg of
`paromomycin base (as the sulfate).
`Injection: 100 mg/ mL, 1 vial = 30 mL or 30%,
`equivalent to approximately 8.1% antimony
`(pentavalent) in 5- mL ampoule.
`
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`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*
`
`artemether*
`
`artemether + lumefantrine*
`
`artesunate*
`
`artesunate + amodiaquine*
`
`artesunate + mefloquine
`
`Tablet: 153 mg or 200 mg (as hydrochloride).
`
`* To be used in combination with artesunate 50 mg.
`
`Oily injection: 80 mg/ mL in 1- mL ampoule.
`
`* For use in the management of severe malaria.
`
`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.
`
`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]; 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.
`
`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.
`Tablet: 25 mg + 55 mg; 100 mg + 220 mg.
`
`Oral liquid: 50 mg (as phosphate or sulfate)/5 mL.
`
`chloroquine*
`
`Tablet: 100 mg; 150 mg (as phosphate or sulfate).
`
`* For use only for the treatment of P.vivax infection.
`
`Capsule: 100 mg (as hydrochloride or hyclate).
`
`doxycycline*
`
`Tablet (dispersible): 100 mg (as monohydrate).
`
`mefloquine*
`
`* For use only in combination with quinine.
`
`Tablet: 250 mg (as hydrochloride).
`
`* To be used in combination with artesunate 50 mg.
`
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`primaquine*
`
`quinine*
`
`sulfadoxine + pyrimethamine*
`
`6.5.3.2 For prophylaxis
`
`chloroquine*
`
`doxycycline a
`
`mefloquine a
`
`proguanil*
`
`Tablet: 7.5 mg; 15 mg (as diphosphate).
`
`* Only for use to achieve radical cure of P.vivax and
`P.ovale