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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 December 2013

6 december 2013

NewsHumanPharmacovigilance

PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously untreated patients

6 december 2013

Press releaseHumanPharmacovigilance

Further review of Iclusig started

6 december 2013

Press releaseHumanPharmacovigilance

European Medicines Agency applies greater fee-reduction rates for orphan medicines in 2014

3 december 2013

NewsCorporateMedicines

Regulatory information – adjustment of linguistic review timetable for opinions adopted at December CHMP meeting

2 december 2013

NewsCorporate

European Medicines Agency website unavailable Sunday 1 December 2013

29 november 2013

NewsCorporateMedicines

European Medicines Agency closed 23 December 2013 to 2 January 2014

29 november 2013

NewsCorporateMedicines

Early dialogue between regulators and health technology assessment bodies key to medicines development

28 november 2013

Press releaseCorporate

World AIDS Day 2013 – Revised guidance to facilitate development of new medicines

28 november 2013

NewsCorporate

European SME Week – early dialogue with the EMA is key to success

26 november 2013

NewsCorporateSME