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European Medicines Agency (EMA)

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Boehringer Ingelheim implements additional guidance supporting appropriate use of Pradaxa® (dabigatran etexilate) in Europe

27 October 2011 | By Boehringer Ingelheim

Update across Europe on Pradaxa®...

news

European CHMP adopts positive opinion for Eviplera(R)

23 September 2011 | By Gilead Sciences, Inc.

CHMP, has adopted a positive opinion on the company's Marketing Authorisation Application for the once-daily single-tablet regimen, Eviplera(R)...

news

EMA accepts marketing authorization application for Ridaforolimus, investigational mTOR inhibitor

18 August 2011 | By

Merck to pay ARIAD $25 million milestone payment for acceptance of filing...

news

Pfizer announces EMA acceptance of regulatory submissions for two investigational cancer therapies

17 August 2011 | By Pfizer

EMA accepted Pfizer’s regulatory submissions for review of two investigational compounds...

news

Viramune® (nevirapine) receives CHMP recommendation for approval

27 July 2011 | By Boehringer Ingelheim

The CHMP issued a Positive Opinion recommending the approval of Viramune® (nevirapine)...

news

EMA recommends revised labeling and guidance for pioglitazone-containing products

22 July 2011 | By Takeda Pharmaceutical Company Limited

The EMA has recommended changes to the label of pioglitazone-containing medicines...

news

GSK and Human Genome Sciences receive positive opinion in Europe from the CHMP for Benlysta® (belimumab)

20 May 2011 | By GlaxoSmithKline

The CHMP has issued a positive opinion, recommending marketing authorisation for Benlysta® (belimumab)...

news

Amgen receives CHMP positive opinion for XGEVA(TM) (Denosumab) in the European Union

20 May 2011 | By Amgen

Amgen announced that the CHMP of the EMA has recommended a positive opinion for the marketing authorization of XGEVA™ (denosumab)...

news

CHMP issues positive opinion for Merck’s VICTRELIS™ (boceprevir)

20 May 2011 | By Merck

Merck announced that the CHMP of the EMA has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELIS™...

news

European Medicines Agency’s Committee for Medicinal Products for Human Use issues positive opinion on marketing authorisation application for FAMPYRA

20 May 2011 | By Biogen Idec

Biogen Idec announced that FAMPYRA(R) (prolonged-release fampridine tablets) has been granted a positive opinion for conditional approval from the EMA's CHMP...

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European Medicines Agency (EMA)