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Médicaments

DRAFT guideline on the use of phtalates as excipients in human medicinal products (EMA/CHMP/SWP/362974/2012 du 25 avril 2013)
DRAFT reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use (EMA/CHMP/SWP/272921/2012 du 25 avril 2013)
Final Concept paper on extrapolation of efficacy and safety in medicine development (EMA/129698/2012 du 19 Mars 2013)
ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK M7 - Current Step 2 version - dated 6 February 2013
Concept Paper S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals Dated and endorsed by the Steering Committee on 14 November 2012
DRAFT CONSENSUS GUIDELINE PHOTOSAFETY EVALUATION OF PHARMACEUTICALS S10 - Current Step 2 version - dated 15 November 2012