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

Six new medicines recommended for approval

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 authorisationfor 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 / dolutegravir sodium / 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 / acetylsalicylic acid)for the prevention of atherothrombotic events.

Positive opinion on Vantobra adopted by written procedure

In addition to the positive opinions for the six new medicines adopted at the June 2014 meeting, the EMA would also like to highlight the CHMP’s recommendation to grant a marketing authorisation for the hybrid medicine Vantobra (tobramycin), adopted via written procedure on 2 June 2014.

Seven recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for AvastinEliquisEnbrel,EyleaIsentressKalydeco and Stivarga.

Re-examination of negative opinion on extension of indication for Avastin requested

The marketing-authorisation holder for Avastin has requested a re-examination of the CHMP’s negative opinion recommending the refusal of a change to the marketing authorisation for this medicine, adopted at its May 2014 meeting. The change concerned an extension of indication to add treatment of glioblastoma (an aggressive type of brain cancer). Upon receipt of the grounds of the request for re-examination, the CHMP will re-examine this opinion and issue a final opinion.

Withdrawals of applications

The applications for marketing authorisation for Faldaprevir Boehringer Ingelheim (faldaprevir), and for an extension of indication for Tasigna (nilotinib) have been withdrawn. For more information, please see question-and-answer documents in the grid below.

 

Posted on the EMA website on 27 June 2014