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Committee for Medicinal Products for Human Use (CHMP)

European Medicines Agency recommends authorisation of first medicine for Castleman’s disease

24 March 2014 | By The European Medicines Agency

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the granting of a marketing authorisation for Sylvant (siltuximab)...

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EMA recommends approval of new treatment for platinum-resistant ovarian cancer together with companion diagnostic

24 March 2014 | By The European Medicines Agency

Vynfinit (vintafolide) offers treatment for women with limited therapeutic options; two diagnostic medicines recommended for approval will help identify patients most likely to respond...

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Meeting highlights from the Committee for Medicinal Products for Human Use

24 March 2014 | By The European Medicines Agency

This page provides an overview of the opinions adopted at the March 2014 meeting of the Committee for Medicinal Products for Human Use and other important outcomes...

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Type 2 Diabetes: CHMP recommends empagliflozin for approval

21 March 2014 | By Boehringer Ingelheim

Positive opinion for investigational SGLT2 inhibitor empagliflozin for the treatment of T2D in adults...

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EMA recommends approval of a locally targeted treatment for ulcerative colitis and Crohn’s disease

21 March 2014 | By The European Medicines Agency

Entyvio (vedolizumab) offers a treatment option for patients who do not respond to standard therapies...

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CHMP issues positive opinion for tablet formulation of Merck’s NOXAFIL® (posaconazole)

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®...

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Rare Disease Day 2014 – twelve new orphan medicines available to patients over the past year

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...

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European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions

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...

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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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Novartis reports positive opinion from CHMP for Xolair® in severe form of skin disease CSU, a debilitating form of hives and chronic itch

24 January 2014 | By Novartis

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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Tivicay® (dolutegravir) receives positive CHMP opinion in Europe for the treatment of HIV

21 November 2013 | By GlaxoSmithKline

“We welcome the CHMP’s positive opinion on dolutegravir – it puts us a step closer to offering this new treatment option to people across Europe who are living with HIV...”

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European CHMP adopts positive opinion for Stribild®

22 March 2013 | By Gilead Sciences

Stribild® a once-daily integrase inhibitor-based single tablet regimen for the treatment of HIV-1 infection...

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Novartis receives positive CHMP opinion for Ilaris®

18 January 2013 | By Novartis

"Novartis welcomes the decision by the CHMP in support of the approval of Ilaris in the EU"

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Sanofi receives positive CHMP opinion in the European Union for once-daily Lyxumia® (lixisenatide)

16 November 2012 | By Sanofi

“The CHMP positive opinion for Lyxumia marks an important milestone..."

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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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Committee for Medicinal Products for Human Use (CHMP)