List view / Grid view
4 March 2014 | By The European Medicines Agency
The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees will be coming into effect on Tuesday 1 April 2014...
28 February 2014 | By Merck
Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of a new, investigational tablet formulation of NOXAFIL®...
25 February 2014 | By The European Medicines Agency
Over the past twelve months, a total of 12 medicines for the treatment of rare diseases were recommended for marketing authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use...
21 February 2014 | By The European Medicines Agency
The European Medicines Agency has concluded its review of Protelos/Osseor and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis...
21 February 2014 | By Teva Pharmaceutical Industries Ltd
Innovative new inhaler for asthma and COPD patients
21 February 2014 | By GlaxoSmithKline
GlaxoSmithKline plc announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation for umeclidinium under the proposed brand name Incruse®...
20 February 2014 | By GlaxoSmithKline
GlaxoSmithKline plc and Theravance, Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation for umeclidinium/vilanterol under the proposed brand name Anoro®...
19 February 2014 | By The European Medicines Agency
The European Medicines Agency and the United States Food and Drug AdministrationExternal link icon have set up a new 'cluster' on pharmacovigilance topics...
17 February 2014 | By The European Medicines Agency
The European Medicines Agency is pleased to welcome Dina Tsiambaou as the new Head of IT Development Department in the Information Technology Division...
12 February 2014 | By The European Medicines Agency
The European Medicines Agency has introduced unique product identifiers (UPIs) to track medicines through pre-authorisation procedures...
11 February 2014 | By The European Medicines Agency
The European Medicines Agency has clarified a number of points related to the new categories of variations to the terms of marketing authorisations that were introduced in August 2013. The related question and answer document has been updated to reflect these adjustments...
10 February 2014 | By The European Medicines Agency
The European Medicines Agency has published an update to its guidance for the annual strain change of influenza vaccines...
7 February 2014 | By The European Medicines Agency
The European Medicines Agency reminds marketing authorisation holders that from 1 March 2014 the use of the eSubmission Gateway or web clientExternal link icon will become mandatory for all electronic Common Technical Document submissions...
5 February 2014 | By European Medicines Agency
A total of 11 out of 81 medicines recommended for marketing authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use in 2013 were intended for the treatment of rare diseases...
Novartis announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the use of Xolair®...
