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Committee for Medicinal Products for Human Use (CHMP)

news

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...

news

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...

news

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®...

news

Abbott receives positive opinion for HUMIRA® in non-radiographic axial spondyloarthritis from EMA’s CHMP

25 June 2012 | By Abbott

Abbott announced that the CHMP has issued a positive opinion for HUMIRA®...

news

Novartis receives positive CHMP opinion for once-daily Seebri® Breezhaler® to treat COPD patients in the EU

22 June 2012 | By Novartis

CHMP has adopted a positive opinion for Seebri® Breezhaler®...

news

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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Zinforo receives positive CHMP opinion in the European Union for the treatment of patients with serious skin infections or community acquired pneumonia

22 June 2012 | By AstraZeneca

Zinforo receives positive CHMP opinion...

news

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)...

news

GSK receives positive opinion from European CHMP for pazopanib

25 May 2012 | By GlaxoSmithKline

Positive opinion recommending marketing authorisation for Votrient®...

news

Novartis drug Jakavi(TM) recommended by CHMP for EU approval to treat patients with the life-threatening blood cancer myelofibrosis

20 April 2012 | By Novartis

Upon approval, Jakavi(TM) (INC424, ruxolitinib) will be the first EU approved JAK inhibitor developed to treat patients with myelofibrosis, a rare blood cancer...

news

FORXIGA® (dapagliflozin) Receives Positive CHMP Opinion in the European Union for the Treatment of Type 2 Diabetes

20 April 2012 | By Bristol-Myers Squibb Company

Bristol-Myers Squibb Company and AstraZeneca announced that the CHMP of the EMA has recommended approval of FORXIGA® (dapagliflozin) tablets...

news

Novartis to revise product information in the European Union for high blood pressure drug Rasilez®

17 February 2012 | By Novartis

CHMP concluded the risk-benefit review of Rasilez* (aliskiren)...

news

GSK receives positive opinion in Europe from the CHMP for Nimenrix®

17 February 2012 | By GlaxoSmithKline

The EMA's CHMP has issued a positive opinion recommending marketing authorisation for Nimenrix® (MenACWY-TT)...

news

CHMP recommends approval of BYETTA® for use with basal insulin

17 February 2012 | By Eli Lilly and Company

Patients in pivotal study achieved better glycemic control without weight gain...

news

Abbott receives positive opinion for HUMIRA® in Ulcerative Colitis from EMA’s CHMP

17 February 2012 | By Abbott

Positive opinion based on supporting data from two Phase III clinical studies...

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Committee for Medicinal Products for Human Use (CHMP)