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WHO Pharmaceuticals Newsletter 2005, No. 02
(2005; 22 pages) View the PDF document
Table of Contents
Open this folder and view contentsREGULATORY MATTERS
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUGS OF CURRENT INTEREST
Open this folder and view contentsFEATURE

WHO Pharmaceuticals Newsletter 2005, No. 02

prepared in collaboration with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden

The aim of this Newsletter is to disseminate information on the safety and efficacy of pharmaceutical products, based on information received from our network of "drug information officers" and other sources such as specialized bulletins and journals, as well as partners in WHO. The information is produced in the form of résumés in English, full texts of which may be obtained on request from:

Quality Assurance and Safety:

Medicines, PSM-HTP
World Health Organization,
1211 Geneva 27, Switzerland
E-mail address: pals@who.int

This newsletter is also available on our Internet website: http://www.who.int/medicines Further information on adverse reactions may be obtained from the WHO Collaborating Centre for International Drug Monitoring, Stora Torget 3, 753 20 Uppsala, Sweden

Tel: 46-18-65.60.60
Fax: 46-18-65.60.80
E-mail: sten.olsson@who-umc.org

Issues around best pharmacovigilance practices and crisis management continue to occupy us even as the medical world struggles to understand the full picture with drugs such as the coxibs. Rofecoxib was withdrawn worldwide in September 2004 and in April 2005, the United States Food and Drug Administration asked Pfizer to voluntarily withdraw valdecoxib from the market. Several regulatory agencies have responded by issuing safety information and prescribing guidelines for various COX-2 inhibitors and these are presented in this edition.

The UN Prequalification Project was launched in 2001 for providing quality assessment on a selected number of medicines for high impact diseases that are considered for purchase by several UN agencies. We have included an overview of the team's work under 'Feature' and regular updates of products which have been prequalified by WHO will appear in future issues of the Newsletter.

The World Health Assembly will take place this year from 16 to 25 May, in Geneva. The WHO Collaborating Centre for International Drug Monitoring is holding its biennial training course on Pharmacovigilance from 23 May to 3 June in Uppsala, Sweden. For those of you who will attend either of these events, we hope they will provide opportunities and incentives for promoting health care and pharmacovigilance in your countries.

© World Health Organization 2005

All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: bookorders@who.int). Requests for permission to reproduce or translate WHO publications - whether for sale or for noncommercial distribution - should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: permissions@who.int).

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization 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 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 the World Health Organization 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 express 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.

This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization.


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