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European Medicines Agency (EMA)

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EMA approves extended Xaluprine shelf life

2 July 2013 | By Nova Laboratories Ltd

The European Medicines Agency has approved an extension of the in-use shelf life for Xaluprine...

news

European Medicines Agency recommends approval of Hexyon/Hexacima 6-in-1 pediatric vaccine

22 February 2013 | By Sanofi

The EMA recommended market approval for Sanofi Pasteur’s 6-in-1 pediatric vaccine...

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Novartis drug Exjade® recommended by CHMP for EU approval

16 November 2012 | By Novartis

The CHMP of the EMA adopted a positive opinion for Exjade®...

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Novartis receives positive CHMP opinion for Bexsero®

16 November 2012 | By Novartis

The CHMP of the EMA has adopted a positive opinion for Bexsero for use in individuals from 2 months of age and older...

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Roche receives positive opinion from EMA for Avastin based treatment beyond first progression in people with advanced colorectal cancer

16 November 2012 | By Roche

The continued use of Avastin based therapy beyond first progression in metastatic colorectal cancer patients leads to survival benefits...

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European Medicines Agency accepts regulatory submission for bazedoxifene/conjugated estrogens

19 July 2012 | By Pfizer

The EMA has accepted for review the MAA for bazedoxifene/conjugated estrogens...

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Sanofi-aventis withdraws its marketing authorisation application for Mulsevo

9 July 2012 | By European Medicines Agency (EMA)

The EMA has been notified by Sanofi-aventis of its decision to withdraw its marketing authorisation application for Mulsevo...

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European Commission positive decision on flutiform®

3 July 2012 | By FTI Consulting

The European Commission has adopted a legally binding decision in favour of granting of marketing authorisations for flutiform®...

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CHMP recommends Novartis drug Afinitor® for EU approval marking major milestone in the treatment of advanced breast cancer

22 June 2012 | By Novartis

Positive opinion for Afinitor® tablets...

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EMA validates Gilead’s marketing application for Elvitegravir for treatment of HIV infection

18 June 2012 | By Gilead Sciences

Gilead Sciences announced that its MAA for elvitegravir has been validated by the EMA...

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Genzyme submits applications to FDA and EMA for approval of LEMTRADA™ (alemtuzumab) for multiple sclerosis

12 June 2012 | By Sanofi

Genzyme is developing LEMTRADA in MS in collaboration with Bayer HealthCare...

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Novo Nordisk receives positive opinion on recombinant factor XIII from the European regulatory authorities

25 May 2012 | By Novo Nordisk

Novo Nordisk receives a positive opinion on recombinant factor XIII product (rFXIII)...

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GSK receives positive opinion from European CHMP for pazopanib

25 May 2012 | By GlaxoSmithKline

Positive opinion recommending marketing authorisation for Votrient®...

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Jentadueto™ tablets recommended for approval in the treatment of adults with Type 2 Diabetes in Europe

25 May 2012 | By Boehringer Ingelheim

Boehringer Ingelheim and Eli Lilly and Company has received a positive opinion from the EMA...

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Genzyme announces regulatory approvals of expanded Waterford, Ireland manufacturing plant

3 May 2012 | By Sanofi

FDA and the EMA approve 2nd operation for filling and finishing product...

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European Medicines Agency (EMA)