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Joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop takes place today

10 marts 2014

NewsHumanRare diseases

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 March 2014

7 marts 2014

NewsHumanPharmacovigilance

PRAC recommends restricting use of domperidone

7 marts 2014

Press releaseHumanPharmacovigilance

PRAC re-examines diacerein and recommends that it remain available with restrictions

7 marts 2014

Press releaseHumanPharmacovigilance

PRAC recommends product information of zolpidem be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness

7 marts 2014

Press releaseHumanPharmacovigilance

EMA and FDA extend pilot programme for parallel assessment of quality-by-design applications

6 marts 2014

NewsHuman

Regulatory information - adjusted fees for applications to European Medicines Agency from 1 April 2014

3 marts 2014

NewsCorporateMedicines

Rare Disease Day 2014 – twelve new orphan medicines available to patients over the past year

25 februar 2014

NewsHumanRare diseases

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 February 2014

21 februar 2014

NewsHuman

European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions

21 februar 2014

Press releaseHumanMedicines