E-MED: Contrefa�on d'antir�troviraux en C�te d'Ivoire
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[Mod�rateur: sur le site de l'OMS/EDM vous pouvez trouver le communiqu�
ci-dessous qui indique que l'Agence fran�aise de s�curit� des produits de
sant� a analys� le Ginovir 3D, compos� du zidovudine (200 mg), du lamivudine
(150 mg) et de l'indinavir (40 mg) et n'a pas trouv� de pr�sence de
lamivudine et de l'indinavir. A la place, ils ont trouv� 201 mg de
zidovudine, 40 mg de stavudine par g�lule, et une substance non identifi�e.
Le fabricant du Ginovir 3D, indiqu� sur la boite, est Selchi
Pharmaceuticals, PO Box 3351, Windhoek Namibia. CB]
WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE
QSM/MC/IEA.110 28 November 2003
Information Exchange System
Alert No. 110
http://www.who.int/medicines/library/qsm/drugalert/alert110.pdf
Counterfeit triple antiretroviral combination product (Ginovir 3D) detected
in C�te d�Ivoire
The World Health Organization has received information about the presence of
a counterfeit triple antiretroviral combination product, Ginovir 3D
capsules, in C�te d�Ivoire. The product was analysed by the Agence Fran�aise
de S�curit� Sanitaire des Produits de Sant� (AFSSAPS) under request from the
association of AIDS patients (Association AIDES) in C�te d�Ivoire. As per
the label, each capsule of Ginovir 3D is stated to contain zidovudine (200
mg), lamivudine (150 mg) and indinavir (40 mg). However, according to
AFSSAPS, laboratory investigations of Ginovir 3D samples did not show the
presence of lamivudine or indinavir; the capsules were found to contain 201
mg of zidovudine and 40 mg of stavudine per capsule, in addition to an
nonidentified substance. The manufacturer of Ginovir 3D, as indicated in the
product, is Selchi Pharmaceuticals, PO Box 3351, Windhoek Namibia.
This message is intended to help Member States stay alert to the possible
presence of this product in their countries and to initiate appropriate
safety and regulatory measures.
Reference:
Bulletin d�Analyse No 2003/U/NX/20391/M/ NC, Direction des Laboratoires et
des Contr�les, (date de notification 11 juillet 2003)AFSSAPS.
CH-1211 GENEVA 27-SWITZERLAND QSM Fax (+41 22) 791.47.30 E-mail: QSM@who.int
http://www.who.int/medicines CH-1211 GENEVE 27-SUISSE
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