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Teva receives CHMP positive opinion for DuoResp® Spiromax® for the treatment of patients diagnosed with Asthma and COPD in Europe
21 February 2014 | By Teva Pharmaceutical Industries Ltd
Innovative new inhaler for asthma and COPD patients
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European Medicines Agency (EMA)
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GSK receives positive CHMP opinion for Incruse® (umeclidinium) for the treatment of COPD
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®...
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Anoro® (umeclidinium / vilanterol) receives positive opinion from the CHMP in Europe for the treatment of COPD
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®...
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European Medicines Agency and US Food and Drug Administration strengthen collaboration in pharmacovigilance area
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...
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European Medicines Agency welcomes new Head of IT Development Department
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...
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EMA introduces product numbers to track medicines through pre-authorisation procedures
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...
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EMA clarifies interpretation of new variation classification categories
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...
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European Medicines Agency updates guidance for annual strain change of seasonal influenza vaccines
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...
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eSubmission Gateway or web client mandatory for all eCTD submissions through the centralised procedure
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...
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Committee for orphan medicines – overview of 2013 and looking ahead
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...
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Novartis reports positive opinion from CHMP for Xolair® in severe form of skin disease CSU, a debilitating form of hives and chronic itch
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®...
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Hepatitis C: Boehringer Ingelheim’s faldaprevir granted accelerated assessment from European Medicines Agency
26 November 2013 | By Boehringer Ingelheim
The application for European marketing authorisation of faldaprevir* has been fully validated and granted accelerated assessment by the European Medicines Agency...
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Novo Nordisk and Roche Diabetes Care are joining forces to make insulin pump therapy simpler for people with diabetes
22 November 2013 | By Novo Nordisk
Insulin aspart PumpCart® is a 1.6 ml prefilled insulin pump cartridge containing the rapid-acting insulin aspart...
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CHMP determines Dimethyl Fumarate in TECFIDERA® to be a new active substance in the European Union
22 November 2013 | By Biogen Idec
This designation will provide 10 years of regulatory exclusivity for TECFIDERA in the European Union...
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Xigduo™ receives positive CHMP opinion in the European Union for the treatment of type 2 diabetes
22 November 2013 | By AstraZeneca
Xigduo™ combines dapagliflozin (tradename Forxiga®), a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride in a twice daily tablet...
