Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 June 2014

EMA

The CHMP recommended six new medicines for approval at its 23-26 June 2014 meeting.

The CHMP has recommended granting a marketing authorisation for Daklinza (daclatasvir) in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. Please see the press release in the grid below for more information.

Abasria (insulin glargine) received a positive opinion for a marketing authorisation for the treatment of diabetes mellitus. Abasria is the first biosimilar insulin to be recommended for marketing authorisation in the European Union.

Vizamyl (flutemetamol (18F)) was recommended for the visual detection of amyloid-beta neuritic plaques in the brain.

Triumeq (abacavir sulfate with dolutegravir sodium and lamivudine) received a positive opinion for a marketing authorisation for the treatment of human immunodeficiency virus (HIV) infection in adults and adolescents from 12 years of age weighing at least 40 kg.

The CHMP gave a positive recommendation for Velphoro (mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) for the control of serum phosphorus levels in patients with end-stage renal disease.

The Committee also recommended granting a marketing authorisation for Clopidogrel/Acetylsalicylic acid Teva (clopidogrel with acetylsalicylic acid) for the prevention of atherothrombotic events.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/06/news_detail_002129.jsp&mid=WC0b01ac058004d5c1

Michael Wonder

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Michael Wonder

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