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European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level

Fri, 17 May 2013 00:00:00 +0200

The European Medicines Agency?s Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the marketing authorisation for Aftovaxpur DOE for use in response to outbreaks of foot-and-mouth disease (FMD).

Benefits of Diane 35 and generics outweigh risks in specific patient group

Fri, 17 May 2013 00:00:00 +0200

The European Medicines Agency?s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in the veins and arteries).

Rapport conjoint de l’EFSA et de l’ECDC : les bactéries résistantes demeurent un problème important pouvant affecter les humains par l’intermédiaire des animaux et des aliments

Thu, 16 May 2013 10:00:00 +0200

European Medicines Agency reorganisation

Fri, 03 May 2013 00:00:00 +0200

The first details of the planned reorganisation of the European Medicines Agency (EMA) have been announced.

Leading experts to review global developments in detecting illicit drugs in wastewater

Thu, 02 May 2013 11:08:00 +0200

European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information

Tue, 30 Apr 2013 00:00:00 +0200

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.

Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh

Mon, 29 Apr 2013 00:00:00 +0200

Following the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Coordination 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).

Recommendation to restrict the use of Protelos / Osseor (strontium ranelate)

Fri, 26 Apr 2013 00:00:00 +0200

The European Medicines Agency?s (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.

European Medicines Agency recommends approval of first treatment for pseudobulbar affect

Fri, 26 Apr 2013 00:00:00 +0200

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.

European Medicines Agency recommends approval of combined advanced-therapy product

Fri, 26 Apr 2013 00:00:00 +0200

The European Medicines Agency?s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Maci (matrix-induced autologous chondrocyte implantation), an advanced-therapy medicinal product (ATMP), for the repair of symptomatic, full-thickness cartilage defects of the knee of 3-20 cm2 in skeletally mature adult patients.