WHO Pharmaceuticals Newsletter 2003, No. 01
(2003; 12 pages) Ver el documento en el formato PDF
Índice de contenido
Cerrar esta carpetaREGULATORY MATTERS
Ver el documentoCISAPRIDE - Highest strength tablets being withdrawn
Ver el documentoCODEINE PREPARATIONS - Products withdrawn due to problems of misuse
Ver el documentoHERBAL - ‘Woman’s Accent’ to be classified as medicinal product
Ver el documentoMISOPROSTOL - Advice against off-label use
Ver el documentoOESTROGENS/ MEDROXY PROGESTERONE ACETATE - Boxed warning against use for the prevention of cardiovascular disease
Ver el documentoPALIVIZUMAB - Label to clarify risk of anaphylaxis, hypersensitivity reactions
Ver el documentoPIPER METHYSTICUM - Regulatory update from Malaysia
Ver el documentoRIBAVIRIN - Package inserts revised for co-administration with interferon a-2b
Ver el documentoTRADITIONAL MEDICINES - Several Chinese medicines withdrawn due to presence of prescription and pharmacy-only components
Ver el documentoVALDECOXIB - Label revised to reflect hypersensitivity reactions and skin reactions
Ver el documentoZAFIRLUKAST - Product label updated with specific patient-management recommendations
Abrir esta carpeta y ver su contenidoSAFETY OF MEDICINES
Abrir esta carpeta y ver su contenidoDRUGS OF CURRENT INTEREST
Abrir esta carpeta y ver su contenidoFEATURE
Ver el documentoEVENTS & 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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Última actualización: le 3 mayo 2013