List view / Grid view
2 May 2014 | By The European Medicines Agency
The European Medicines Agency has presented the European Commission with its first report on the tasks it undertook during the first year of application of the EU’s new pharmacovigilance legislation...
29 April 2014 | By The European Medicines Agency
In 2013, EudraVigilance received more than one million post-marketing expedited adverse-drug-reaction reports...
17 April 2014 | By The European Medicines Agency
The European Medicines Agency has been informed that vials of the cancer medicine Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries...
11 April 2014 | By The European Medicines Agency
The Pharmacovigilance Risk Assessment Committee gave a recommendation on one safety review and started four new safety reviews at its April meeting...
9 April 2014 | By The European Medicines Agency
Targeted discussions with key stakeholders in May...
7 April 2014 | By The European Medicines Agency
In a meeting at the European Medicines Agency on 4 April 2014, the EMA’s Executive Director, Prof. Guido Rasi, and the National Manager of the Australian Therapeutic Goods AdministrationExternal link icon, Prof. John Skerritt, announced that the two regulators have agreed to share the full assessment reports...
1 April 2014 | By Shire
Shire plc announced the acceptance of submission of a Marketing Authorisation Application by the European Medicines Agency for their once-daily, non-stimulant guanfacine extended release...
26 March 2014 | By The European Medicines Agency
Handling of all other evaluation procedures to remain unchanged until further announcement later this year...
26 March 2014 | By GlaxoSmithKline
GlaxoSmithKline plc announced that the European Commission has granted marketing authorisation for its once-weekly diabetes treatment, Eperzan® (albiglutide)...
24 March 2014 | By The European Medicines Agency
Restrictions intended to limit risks of severe diarrhoea and effects on the liver...
24 March 2014 | By The European Medicines Agency
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the granting of a marketing authorisation for Sylvant (siltuximab)...
24 March 2014 | By The European Medicines Agency
Vynfinit (vintafolide) offers treatment for women with limited therapeutic options; two diagnostic medicines recommended for approval will help identify patients most likely to respond...
24 March 2014 | By The European Medicines Agency
This page provides an overview of the opinions adopted at the March 2014 meeting of the Committee for Medicinal Products for Human Use and other important outcomes...
21 March 2014 | By The European Medicines Agency
Entyvio (vedolizumab) offers a treatment option for patients who do not respond to standard therapies...
19 March 2014 | By The European Medicines Agency
The European Medicines Agency has published its work programme for 2014...
