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PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors

14 juni 2013

Press releaseHumanPharmacovigilance

PRAC recommends restricting the use of codeine when used for pain relief in children

14 juni 2013

Press releaseHumanPaediatricsPharmacovigilance

PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl starch

14 juni 2013

Press releaseHumanPharmacovigilance

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013

14 juni 2013

NewsHumanPharmacovigilance

Revised guideline on biosimilars containing biotechnology-derived proteins published for public consultation

10 juni 2013

NewsHumanBiosimilarsRegulatory and procedural guidance

European Medicines Agency publishes interim fee advice for bluetongue-vaccine manufacturers

7 juni 2013

NewsCorporateMedicines

Public consultation open on guideline on the acceptability of names for human medicines

7 juni 2013

NewsCorporateRegulatory and procedural guidance

Comments invited on good-pharmacovigilance-practice module on reporting of adverse reactions

7 juni 2013

NewsCorporate

European Medicines Agency and EUnetHTA review progress of their cooperation

7 juni 2013

Press releaseCorporateMedicines

Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders

5 juni 2013

NewsCorporate