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CURRENT WORK PLAN New Monographs for Inclusion in the International Pharmacopoeia and Revision of Related Monographs

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CURRENT WORK PLAN New Monographs for Inclusion in the International Pharmacopoeia and Revision of Related Monographs page 1 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 *. page 2 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 page 3 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 ) page 4 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 page 5 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 page 6 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 page 7 6. Other medicines (other antivirals, analgesics, antipyretics, palliative care agents, anti-epileptics, LVPs 1, 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 page 8 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 *** .
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