May 3, 2013
- The European Medicines Agency's website, ema.europa.eu, will be unavailable between 9.00am and 5.30pm on Saturday 4 May 2013, due to essential maintenance.
- The first details of the planned reorganisation of the European Medicines Agency (EMA) have been announced.
April 30, 2013
- The European Medicines Agency (EMA) has published the final advice from the advisory groups that have been set up to inform the EMA in drafting its policy on proactive access to clinical-trial data.
- The European Medicines Agency has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court.
April 29, 2013
- The European Medicines Agency is closed from 6.30pm on Tuesday 30 April until 7.30am on Thursday 2 May 2013.
- Following the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-containing medicines across the European Union (EU).
April 26, 2013
- The European Medicines Agency (EMA) supports World Veterinary Day, taking place on Saturday 27 April 2013.
- This page provides an overview of the opinions adopted at the April 2013 meeting of the CHMP and other important outcomes.
- The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Nuedexta, a medicine for the treatment of pseudobulbar affect in adults.
- The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended a restriction in the use of the osteoporosis medicine Protelos/Osseor, following an assessment of data showing an increased risk of serious heart problems.