15th Expert Committee on the Selection and Use of Essential Medicines

 

Applications:

 

NEW FORMULATIONS
Drug name Formulation Application prepared by: Comments
Aciclovir

Section 21.01.00.00 - Ophtalmological preparations. Anti-infective agents.

Aciclovir 3.0% W/W ointment
FOR OPHTHALMIC USE ONLY
Cochrane Eyes and Vision Group www.cochraneeyes.org
International Centre for Eye Health, London School of Hygiene and Tropical
Medicine, Keppel St, London, UK.
V2020 technology working group
 

Expert  reviews

Antevenom serum:
Equine immunoglobuline F(ab')2 fragments

19.02.00.00 - Sera and immunoglobulins
 

Solution for slow intravenous injection, in vial Michael Attlan, Director, Traveler and Endemic Risk Franchise, Sanofi Pasteur, 2 av. Pont Pasteur, F-69367 Lyon cedex 07 France
 

Expert  reviews

Public
 

Artesunate

Section 06.05.03.01: Antimalarial medicines -
For curative treatment.

See page 20 Dr P. Olumese, Global Malaria Programme, World Health Organization, Geneva, Switzerland

Expert  reviews

Expert Panel

Public
 

Efavirenz

Section 06.04.02.02 - Non-nucleoside reverse transcriptase inhibitors
 

600 mg MERCK SHARP & DOHME Interpharma
La Celle Saint Cloud, FRANCE
 

Public

Efavirenz, emtricitabine and tenofovir disoproxil fumarate FDC tablet

Section 06.04.02.00 - Antiretrovirals
 

Each tablet contains 600 mg efavirenz, 200 mg emtricitabine and 300 mg of tenofovir DF,
equivalent to 245 mg of tenofovir disoproxil.
MERCK SHARP & DOHME Interpharma
La Celle Saint Cloud, FRANCE

Expert  reviews

Public
 

Lamivudine/stavudine/nevirapine

Formulary text
 

Lamivudine/zidovudine/nevirapine

Formulary text
 

Lamivudine/zidovudine

Formulary text

Section 06.04.02.01 - Antiretrovirals -- Nucleoside reverse transcriptase inhibitors
 

 

 

Charles Gilks Coordinator Anti-retroviral Treatment and HIV Care (ATC)

Expert  reviews

Public

Levonorgestrel - releasing implantable contraceptives

Covering letter

Section 18.03.00.00: Contraceptives
 

Two-rod levonorgestrel-releasing implant; each rod containing 75 mg of levonorgestrel (150 mg total).

 

The Geneva Foundation for Medical Education and Research

Expert  reviews

Medroxyprogesterone acetate (DMPA)
25 mg plus estradiol cypionate

Section 18.03.02.00: Injectable hormonal contraceptives
 

Combined injectable contraceptive containing medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E2 C) 5 mg The Geneva Foundation for Medical Education and Research

Expert  reviews

Public

Morphine

Additional information

Section 02.02.00.00 - Opioid analgesics
 

Slow release tablet Phil Wiffen, supported by the International Association for Hospice and Palliative Care

Expert  reviews

Public

WHO

Rifampicin 150 mg + isoniazid 75 mg + ethambutol 275 mg

Section 06.02.04.00: Antituberculosis medicines
 

Oral tablet for adults. Dr Arnaud Trebucq, The international Union Against Tuberculosis and Lung Disease
Dr Myriam Henkens, Medecins Sans Frontieres

Expert  reviews

NEW MEDICINES
Drug name Formulation Application prepared by: Comments
Cefalosporins: Cefazolin/Cefalexin

Antibacterials
Section 06.02.01.00 - Beta-Lactam medicines

Cefazolin - parenteral ( injectable)1gm/vial

Cefalexin  - Oral

Capsules - 250mg/capsule and 500mg/capsule

Syrup - powder to be reconstituted with water - 125mg/5ml and 250mg/5ml
 

Dr Elizabeth Mathai (for the Department of Medicines Policy and Standards, HTP/PSM)
 

Expert  reviews

Emtricitabine

References

Section 06.04.02.01 - Antiretrovirals - Nucleoside reverse transcriptase inhibitors
 

Capsule 200 mg

Oral solution 10 mg/1ml

Daniel E. Kates, M.D., Director, Medical Communications, Gilead Sciences Inc.

Expert  reviews

Emtricitabine and tenofovir disoproxil fumarate fixed-dose combination

References

Section 06.04.02.01 - Antiretrovirals - Nucleoside reverse transcriptase inhibitors
 

Tablet 200 mg emtricitabine and 300 mg tenofovir DF, equivalent to 245 mg of tenofovir disoproxil Daniel E. Kates, M.D., Director, Medical Communications, Gilead Sciences Inc.

Expert  reviews

Public

Supplement to application for inclusion of tenofovir disoproxil fumarate(DF), emtricitabine and emtricitabine/tenofovir DF FDC

References
 
  Daniel E. Kates, M.D., Director, Medical Communications, Gilead Sciences Inc.  

Fluoxetine hydrochloride

Section 24.02.01.00: Medicines used in depressive disorders

20 mg tablets

 

WHO Collaborating Centre for Research and Training in Mental Health, Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona, Policlinico G.B. Rossi, Piazzale Scuro 10, 37134 Verona, Italy.

Expert  reviews

Public

WHO
 

Immunoglobulins (See Re-instatement)

Paromomycin sulfate

Abstract presented at the 2004 meeting of the American Society of Tropical Medicine and Hygiene

Population pharmacokinetics of paromomycin sulfate in Indian visceral leishmaniasis patients

References

Section 06.05.02.00 - Antileishmaniasis medicines
 

2-ml ampoule containing paromomycin sulfate equivalent to 750 mg of paromomycin.

Dr Ahvie Herskowitz MD, Chief Medical Officer, Institute for OneWorld Health, 50 California Street, Suite 500, San Francisco, California 94111, USA

Expert  reviews

Public

WHO
 

Ribavirin

REBETOL (ribavirin, USP) Capsules (Appendix 3)

Section 06.04.03.00 - Other antivirals
 

Vials containing 1000 mg and 800 mg of ribavirin dissolved in 10ml phosphate buffer solution.
Ribavirin for oral administration: capsules or film-coated tablets, 200 mg
 
Dr Cathy Roth, Coordinator, Biorisk Reduction for Dangerous Pathogens Team (BDP)
Department of Epidemic and Pandemic Alert and Response (CDS/EPR)
Dr Pierre Formenty, Project Leader for Dangerous Pathogens, CDS/EPR/BDP

Expert  reviews

Public
 

Simvastatin (example of a class)

Appendix A: Global manufacturers of a generic statin (simvastatin)

Appendix B: List of the selected secondary studies

Appendix C: Past and present cost of statins

Section 12.06.00.00: Lipid-lowering agents
 

Simvastatin: tablets containing 5, 10, 20, 40 or 80 mg
Pravastatin: tablets containing 10, 20, 40 mg
Lovastatin: tablets containing 10, 20, 40 mg
Fluvastatin: tablets containing 20, 40 mg (capsules); 80 (XL tablets)
Atorvastatin: tablets containing 10, 20, 40, 80 mg

NHS Centre for the Evaluation of Effectiveness of Health Care (CeVEAS)
Local Health Unit Modena, Italy
Universities Allied for Essential Medicines (UAEM), Weill Cornell Medical College - The Rockefeller University - Sloan-Kettering Cancer Institute Chapter, New York, New York (USA)
 

Expert  reviews

WHO

Sumatriptan

Section 07.01.00.00: Antimigraine medicines for treatment of acute attack
 

Sumatriptan tablets 50 mg

 

Global Campaign to Reduce the Burden of Headache Worldwide, a joint venture between WHO, EHF, WHA, and IHS

Expert  reviews

WHO
 

Tenofovir disoproxil fumarate (TDF)

References

Section 06.04.02.01 - Antiretrovirals - Nucleoside reverse transcriptase inhibitors
 

Tablet 300 mg tenofovir disoproxil fumarate equivalent to 245 mg tenofovir disoproxil Daniel E. Kates, M.D., Director, Medical Communications, Gilead Sciences Inc.

 

Expert  reviews

SECTION REVIEW
Drug name Formulation Application prepared by: Comments
Antituberculosis medicines
(Quinolones for multi-drug resistant TB)

Section 06.02.04.00
 

   

Expert  reviews

WHO
 

Antimalarial medicines

Section 06.05.03.00
 

See page 3 Dr P. Olumese, Global Malaria Programme, World Health Organization, Geneva, Switzerland

 

Expert  reviews

Antitrypanosomal medicines

Section 06.05.05.01 - African trypanosomiasis

?     Innovative and Intensified Disease Management

Neglected Tropical Diseases

World Health Organization

Geneva, Switzerland

 

Medecins Sans Frontieres

8, rue Saint Sabin

75011 Paris, France
 

Expert  reviews

Public

Cytotoxic medicines

Covering letter

Section 08.02.00.00
 

See Deletions    
Medicines used in palliative care

Cover letter

IAHPC list of essential medicines for palliative care

Summary of process for editors of pain and palliative care journals

Section 08.04.00.00
 

  The international Association for Hospice and Palliative Care, USA

Expert  reviews

Contraceptives

Section 18.03.00.00
  Dr A. Lofts Gray, University of KwaZulu-Natal, South Africa
Dr J. A. Smit, Dr N. Manzini,
Dr M. Beksinska, University of the Witwatersrand, South Africa

Expert  reviews

Public

WHO
 

Vaccines

Section 19.03.00.00
 

  IVB/WHO

Expert  reviews

Ophthalmological preparations

Section 21.00.00.00

See appendices Mr R. Wormald MA, MB, MSc, FRCS, FRCOphth, International Centre of Eye Health, School of Hygiene and Tropical Medicine, London and Moorfields Eye Hospital, London
 

Expert  reviews

 

 

Applications for paediatric medicines:

 

NEW FORMULATIONS
Drug name Formulation Application prepared by: Comments

Antivenom serum:
Equine immunoglobuline F(ab')2 fragments

 

Section 19.02.00.00 - Sera and immunoglobulins
 

Solution for slow intravenous injection, in vial Michael Attlan, Director, Traveler and Endemic Risk Franchise, Sanofi Pasteur, 2 av. Pont Pasteur, F-69367 Lyon cedex 07 France
 

Expert  reviews

Artemether/lumefantrine

Stability of the artemether/lumefantrine suspension

Section 06.05.03.00 - Antimalarial medicines

Powder for suspension Dr F.H. Jansen, Medical and R&D Director, Dafra Pharma nv, Slachthuisstraat 30 bus 7, B-2300 Turnhout, Belgium
 

Expert  reviews

Public

WHO
 

Carbamazepine

Bibliographic reference

International Drug Price Indicator

Section 05.00.00.00 - Anticonvulsants/epileptics
(for children)
 

Oral suspension (100 mg/5 ml), 100 mg and 200 mg chewable tablets Dr Tony Nunn, Clinical Director of Pharmacy, Royal Liverpool Children's NHS Trust, Eaton Road, Liverpool L12 2 AP, UK

Expert  reviews

WHO

Isoniazid

Formulary text

Section 06.02.04.00: Antituberculosis medicines

50 mg scored oral tablet Dr Hanne Bak Pedersen, UNICEF
Dr Arnaud Trebucq, The international Union Against Tuberculosis and Lung Disease
Dr Jerome van Gorkorn, KNCV Tuberculosis Foundation
 

Expert  reviews

Phenobarbitone:

Section 05.00.00.00 - Anticonvulsants/epileptics
(for children)
 

Injectable 200mg/ml, 1ml Prof. Josemir W. Sander, WHO Collaborating Centre for Research and Training in Neurosciences; Department of Clinical and Experimental Epilepsy, UCL Institute of Neurology, Queen Square, London WC1N 3BG, United Kingdom

Expert  reviews

WHO

Phenytoin

Bibliographic references

Section 05.00.00.00 - Anticonvulsants/epileptics
(for children)
 

50 mg chewable tablet and oral suspension 30 mg/5 ml  

Expert  reviews

WHO
 

Pyrazinamide

Formulary text

Section 06.02.04.00: Antituberculosis medicines
 

150 mg dispersable tablet, oral tablet Dr Hanne Bak Pedersen, UNICEF
Dr Arnaud Trebucq, The international Union Against Tuberculosis and Lung Disease
 

Expert  reviews

Retinol palmitate (Vitamin A)

Section 27.00.00.00: Vitamins and minerals

50 000 IU and 100 000 IU capsules Dr E. Magrath and Prof. N. Cranswick, Clinical Pharmacology Unit, General Medicine, Royal Children's Hospital, Melbourne, Australia
Dr J. Kelly and Prof. T. Duke, Centre for International Child Health, Department of Paediatrics, University of Melbourne, Australia

Expert  reviews

Valproic acid (Sodium valproate)

Bibliographic reference

International Drug Price Indicator

Section 05.00.00.00 - Anticonvulsants/epileptics
(for children)
 

Sugar free liquid and oral syrup 200mg in 5ml; sodium valproate
100mg crushable tablets.
Dr Tony Nunn, Clinical Director of Pharmacy, Royal Liverpool Children's NHS Trust, Eaton Road, Liverpool L12 2 AP, UK

Expert  reviews

WHO

NEW MEDICINES
Drug name Formulation Application prepared by: Comments
Caffeine citrate

Section 25.02.00.00: Other medicines acting on the respiratory tract
 

Oral solution, caffeine citrate 20 mg/ml

Injection, (solution for injection) 20 mg/ml

Dr Sean Beggs and Dr Trevor Duke, Royal Children's Hospital, Melbourne, Australia

Expert  reviews

 

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Last update:19-Jun-2007