WHO Pharmaceuticals Newsletter 2004, No. 04
(2004; 14 pages) Voir le document au format PDF
Table des matières
Fermer ce répertoireREGULATORY MATTERS
Afficher le documentALOSETRON - Risk management plan to remain in place
Afficher le documentANTIDEPRESSANTS - Health Canadaendorsed safety information
Afficher le documentBUPROPION - Labelling updated to include class warning
Afficher le documentCLOZAPINE - Labelling to include updated patient safety registry information
Afficher le documentDEXTROPROPOXYPHENE/PARACETAMOL - Prescribing reminder
Afficher le documentDOMPERIDONE - Not to be used to increase milk production in women
Afficher le documentLEFLUNOMIDE - Update on interstitial lung disease
Afficher le documentROSUVASTATIN - Higher dose and predisposing factors linked with rhabdomyolysis
Afficher le documentSULPHUR HEXAFLUORIDE - Use in echocardiography suspended
Ouvrir ce répertoire et afficher son contenuSAFETY OF MEDICINES
Afficher le documentANNOUNCEMENT
 

BUPROPION - Labelling updated to include class warning

Canada. Following discussions with Health Canada, Biovail Pharmaceuticals has advised of bupropion-associated behavioural and emotional changes in a "Dear Healthcare Professional" letter. Bupropion is marketed in Canada as the antidepressant Wellbutrin SR and the smoking cessation drug Zyban, and a Class warning regarding behavioural and emotional changes, including risk of self-harm, has been added to the labelling of both products. This warning applies to both paediatric and adult patients, although neither of these products is indicated for use in patients aged <18 years.

Reference:

"Dear Healthcare Professional" letter from Bioavail Pharmaceuticals, 8 June 2004. Available on the Internet at www.hc-sc.gc.ca

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Dernière mise à jour: le 3 mai 2013