This page lists the opinions adopted at the April 2012 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

The new format allows users to view the main opinions adopted at the meeting, along with information on referral procedures, in a clear tabular format. Users can click on the links within the page to read individual press releases and more detailed information about the opinions.

The new format replaces the two PDF documents that used to list each meeting's outcome: the CHMP meeting highlights, published on the Friday following the meeting and the CHMP monthly report, published around a week later. The Agency will publish a new page following each month's CHMP meeting.

The Agency has gathered feedback from journalists and other stakeholders. It will make some changes to the format by May 2012.

Positive opinions on new medicines

Name of medicineINNMarketing authorisation applicant
CHMP summary of positive opinion for Forxiga

Press release: European Medicines Agency recommends authorisation of novel treatment for type 2 diabetes

dapagliflozinBristol-Myers Squibb / AstraZeneca EEIG
CHMP summary of positive opinion for JakaviruxolitinibNovartis Europharm Ltd
CHMP summary of positive opinion for RiensoferumoxytolTakeda Global Research and Development Centre (Europe) Ltd

Final opinions on re-examinations

Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
CHMP post-authorisation summary of positive opinion for Optisulin / CHMP post-authorisation summary of positive opinion for Lantusinsulin glargineSanofi-aventis Deutschland GmbH

Final opinions on safety reviews of centrally authorised medicines

Final opinions on arbitration procedures

Name of medicineINNMarketing authorisation holder
Flutiform / Iffezafluticasone propionate / formoterol fumarateNapp Pharmaceuticals Ltd
Yaz 24+4 / Ethinylestradiol-Drospirenone 24+4ethinylestradiol / drospirenoneBayer PLC
Yviduallyethinylestradiol / drospirenoneBayer B.V.

Other updates

 

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