Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 April 2012

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20/04/2012

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 April 2012

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
Forxiga

Press release: European Medicines Agency recommends authorisation of novel treatment for type 2 diabetes
dapagliflozinBristol-Myers Squibb / AstraZeneca EEIG
JakaviruxolitinibNovartis Europharm Ltd
RiensoferumoxytolTakeda Global Research and Development Centre (Europe) Ltd


Final opinions on re-examinations

Name of medicineINNMarketing authorisation applicant
Glybera

Press release: European medicines Agency maintains recommendation not to grant a marketing authorisation for Glybera
alipogene tiparvovecAmsterdam Molecular Therapeutics B.V.
FolotynpralatrexateAllos Therapeutics Ltd


Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
Optisulin / Lantusinsulin glargineSanofi-aventis Deutschland GmbH


Final opinions on safety reviews of centrally authorised medicines

Name of medicineINNMarketing authorisation holder

Gilenya


Press release: European Medicines Agency gives new advice to better manage risk of adverse effects on the heart with Gilenya

fingolimodNovartis Europharm Ltd


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

Opinions on annual re-assessments and renewals
Opinions on safety variations
Medicines granted a Community marketing authorisation under the centralised procedure from 1-31 March 2012
Scientific advice and protocol assistance
Guidelines and concept papers adopted during the April 2012 CHMP meeting
Overview of invented names reviewed in March 2012 by the Name Review Group (NRG)
Organisational matters

 

Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore users are asked to check the page regularly.

Contact point:

Monika Benstetter or Sabine Haubenreisser
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu