WHO Pharmaceuticals Newsletter 2003, No. 01
(2003; 12 pages) Voir le document au format PDF
Table des matières
Fermer ce répertoireREGULATORY MATTERS
Afficher le documentCISAPRIDE - Highest strength tablets being withdrawn
Afficher le documentCODEINE PREPARATIONS - Products withdrawn due to problems of misuse
Afficher le documentHERBAL - ‘Woman’s Accent’ to be classified as medicinal product
Afficher le documentMISOPROSTOL - Advice against off-label use
Afficher le documentOESTROGENS/ MEDROXY PROGESTERONE ACETATE - Boxed warning against use for the prevention of cardiovascular disease
Afficher le documentPALIVIZUMAB - Label to clarify risk of anaphylaxis, hypersensitivity reactions
Afficher le documentPIPER METHYSTICUM - Regulatory update from Malaysia
Afficher le documentRIBAVIRIN - Package inserts revised for co-administration with interferon a-2b
Afficher le documentTRADITIONAL MEDICINES - Several Chinese medicines withdrawn due to presence of prescription and pharmacy-only components
Afficher le documentVALDECOXIB - Label revised to reflect hypersensitivity reactions and skin reactions
Afficher le documentZAFIRLUKAST - Product label updated with specific patient-management recommendations
Ouvrir ce répertoire et afficher son contenuSAFETY OF MEDICINES
Ouvrir ce répertoire et afficher son contenuDRUGS OF CURRENT INTEREST
Ouvrir ce répertoire et afficher son contenuFEATURE
Afficher le documentEVENTS & ANNOUNCEMENTS
 

HERBAL - ‘Woman’s Accent’ to be classified as medicinal product

UK. The Medicines Control Agency (MCA) has ruled that ‘Woman’s Accent’, an herbal product marketed in the UK, should be classified as a Medicinal Product requiring licensing. Woman’s Accent contains several ingredients such as Blessed thistle, Dong Quai, Wild Yam and Black cohosh. According to the MCA, the product was deemed to be a medicine since it claimed to relieve menstrual problems, prevent bone loss, inhibit growth of cancer cells and restore sexual function, balance progesterone and other hormone levels and to promote diuresis. These claims do not meet the criteria for exemption from licensing.

Reference:
MCA’s Final Determination issued by the Borderline Section, 30 Dec 2003. Available from URL: http://www.mca.gov.uk/ourwork/lic ensingmeds

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Dernière mise à jour: le 3 mai 2013