WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoREGULATORY MATTERS
Cerrar esta carpetaSAFETY OF MEDICINES
Ver el documentoANTIRETRO-VIRALS - Benefit/Risk balance remains strongly positive for combination antiretroviral therapy
Ver el documentoCYPROTERONE ACETATE & ETHINYL-ESTRADIOL - Update on risk of venous thromboembolism
Ver el documentoDIETHYL-STILBESTROL - Gynaecological and obstetric complications after in utero exposure
Ver el documentoEPHEDRA - Moves to reduce risks of ephedra-containing products
Ver el documentoFLUTICASONE PROPIONATE - Reports of adrenal crisis
Ver el documentoGRAPEFRUIT JUICE - Revised advice from ADRAC
Ver el documentoHORMONE REPLACEMENT THERAPY (HRT) - Risk of dementia
Ver el documentoOMEPRAZOLE, RABEPRAZOLE - Reports of interstitial nephritis
Ver el documentoROFECOXIB, CELECOXIB - Case reports support causal association with liver toxicity
Ver el documentoROSIGLITA-ZONE, PIOGLITAZONE - Adverse reactions update
Ver el documentoSOMATROPIN - Not to be authorized for AIDS-related wasting syndrome
Abrir esta carpeta y ver su contenidoCURRENT CONCERNS
Abrir esta carpeta y ver su contenidoDRUGS OF INTEREST
Abrir esta carpeta y ver su contenidoFEATURE
 

SOMATROPIN - Not to be authorized for AIDS-related wasting syndrome

Europe. The European Committee for Proprietary Medicinal Products (CPMP) has ruled out granting a marketing authorization for Serono’s orphan drug somatropin (Serostim), a recombinant growth hormone for AIDS-related wasting syndrome. Doubts about the clinical relevance of the primary endpoints used in the study, the lack of long-term efficacy data under controlled conditions and concerns about the long-term safety profile are being stated as reasons for this decision. The CPMP believes that the quality, safety and efficacy data suggest an unfavourable benefit to risk balance for somatropin (Serostim).

Reference:
CPMP Summary of Opinion (CPMP/5330/02), 25 Apr 2003. Available from URL: http://www.emea.eu.int

 

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