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CURRENT WORK PLAN

New monographs for inclusion in
The International Pharmacopoeia
and revision of related monographs

2011

The following categories are included in this work programme:

1. Medicines used in HIV/AIDS treatment (antiretrovirals - ARVs)
2. Medicines used in malaria treatment
3. Medicines used in TB treatment
4. Anti-infectives (antibacterials, antiprotozoal, antifungal, antiviral, and
antimycobacterial agents, anthelmintics)
5. Oral rehydration therapy
6. Other medicines (other antivirals, analgesics, antipyretics, palliative care
agents, anti-epileptics, large volume parenterals, reproductive health, vitamins,
cytotoxic agents, insulins)

Entries highlighted in red correspond to new additions.

Where a draft monograph has already been provided to the Secretariat for
discussion, this is indicated by means of the symbol *.
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1. Medicines used in HIV/AIDS treatment

(antiretrovirals - ARVs)

APIs:
Atazanavir

Dosage forms:

Emtricitabine oral solution

Ritonavir capsules
Ritonavir oral solution
Stavudine powder for oral solution
Zidovudine tablets
Atazanavir capsules

Fixed-dose combinations (FDC):

Tenofovir and lamivudine tablets

Tenofovir, efavirenz and lamivudine tablets
Atazanavir and ritonavir tablets
Lamivudine and abacavir tablets
Lamivudine, abacavir and nevirapine tablets

Lopinavir and ritonavir capsules

Lopinavir and ritonavir oral solution
Lamivudine and stavudine tablets
Lamivudine, stavudine and nevirapine tablets

Dosage forms, as available for:

Lamivudine + Zidovudine + Efavirenz**

** to confirm with the Disease Programme

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2. Medicines used in Malaria treatment

APIs

Piperaquine phosphate

Dosage forms

Artesunate rectal capsules

Fixed-dose combinations (FDC):

Artemether and lumefantrine capsules

Artemether and lumefantrine dispersible tablets
Artesunate and amodiaquine tablets
Dihydroartemisinin and piperaquine phosphate tablets

Revision
Artemisinin derivatives (APIs and dosage forms)
(see http://www.who.int/medicines/publications/pharmacopoeia/mon_mal/en/index.html)
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3. Medicines used in Tuberculosis (TB) treatment

APIs:

Moxifloxacin
p-Aminosalicylic acid
Terizidone

Dosage forms:

Moxifloxacin tablets/capsules
Ethambutol oral liquid
Pyrazinamide oral syrup

p-Aminosalicylic acid granules

Ethionamide tablets/capsules
Protionamide tablets
Terizidone tablets/capsules
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4. Anti-infectives (antibacterials, antiprotozoals, antifungals,

antivirals, anthelminthics and antimycobacterial agents)

APIs
Azithromycin
Aciclovir
Cefixime
Rifabutin

Ceftriaxone sodium
Fluconazole
Ivermectin

Dosage forms
Azithromycin capsules
Azithromycin oral liquid
Sulfadiazine tablets
Clindamycin capsules
Clindamycin injection
Clindamycin oral liquid
Aciclovir tablets
Aciclovir powder for injection
Aciclovir oral liquid
Spectinomycin powder for injection
Cefixime capsules
Rifabutin capsules

Albendazole chewable tablets

Ceftriaxone injection
Doxycycline dispersible tablets
Fluconazole capsules
Fluconazole injection
Fluconazole oral solution/suspension
Ivermectin tablets
Pyrantel chewable tablets*
Pyrantel oral solution*
Pyrimethamine tablets

Fixed-dose combinations (FDC):

Sulfamethoxazole and trimethoprim injection

Sulfamethoxazole and trimethoprim oral solution/suspension
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5. Oral rehydration therapy

APIs
Zinc acetate
Zinc gluconate

Dosage forms
Paediatric zinc acetate tablets
Paediatric zinc acetate oral solution
Paediatric zinc gluconate oral solution
Paediatric zinc gluconate tablets
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6. Other medicines (other antivirals, analgesics, antipyretics,

palliative care agents, anti-epileptics, LVPs1, reproductive
health, vitamins, cytotoxic agents, insulins)

Dosage forms
Morphine oral solution
Paediatric Retinol oral solution

Antiepileptics
Carbamazepine oral liquid
Carbamazepine chewable tablets
Phenobarbital oral liquid
Phenytoin oral liquid
Phenytoin chewable tablets
Valproic acid oral liquid
Valproic acid crushable tablets

Large volume parenterals

Glucose intravenous infusion
Sodium chloride intravenous infusion
Sodium chloride and glucose intravenous infusion

Reproductive health
APIs
Mifepristone
Misoprostol
Norgestrel

Dosage forms
Mifepristone tablets
Misoprostol tablets
Norgestrel tablets
Norethisterone tablets
Norethisterone injection

Note from Secretariat: used in co-blisters with Misoprostol tablets

Ethinylestradiol + levonorgestrel tablets

Medroxyprogesterone acetate (DMPA), depot injection

1
LVPs: Large Volume Parenterals
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Cytotoxic medicines

Bleomycin powder for injection

Etoposide capsules
Vinblastine powder for injection
Vincristine powder for injection
Calcium folinate tablets
Calcium folinate injection

Insulins

APIs

Insulin, human
Insulin, bovine
Insulin, porcine

Dosage forms

Insulin preparations - General monograph

Insulin injection (soluble)

Insulin zinc suspension
Isophane insulin injection

Insulin zinc suspension (amorphous)**

Insulin zinc suspension (crystalline)**
Biphasic insulin injection**
Biphasic isophane insulin injection **
Protamine zinc insulin injection**

** to confirm with the Disease Programme

***