Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 November 2011

  • Email
  • Help

News

18/11/2011

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 November 2011

This page lists the opinions adopted at the November 2011 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 is gathering feedback from journalists and other stakeholders over the first three months of publication. It will make any necessary changes to the format in early 2012.

Positive opinions on new medicines

Name of medicineINNMarketing authorisation applicant
CaprelsavandetanibAstraZeneca AB


Positive opinions on generics

Name of medicineINNMarketing authorisation applicant
Desloratadine ActavisdesloratadineActavis Group PTC ehf
Desloratadine ratiopharmdesloratadineRatiopharm GmbH
Docetaxel MylandocetaxelMylan S.A.S.


Opinions on re-examination procedures for new medicines

Name of medicineINNMarketing authorisation applicant
Sumatriptan GalpharmsumatriptanGalpharm Healthcare Ltd


Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
ErbituxcetuximabMerck KGaA
HerceptintrastuzumabRoche Registration Ltd
NevanacnepafenacAlcon Laboratories (UK) Ltd
Rebifinterferon beta-1aMerck Serono Europe Ltd


Opinions on re-examination procedures

Name of medicineINNMarketing authorisation holder
Ariclaim, Cymbalta, XeristarduloxetineEli Lilly Nederland B.V.


Final opinions on safety reviews for non-centrally authorised medicines

Name of medicineINN

Buflomedil-containing medicines

Press release: European Medicines Agency recommends suspension of all buflomedil-containing medicines

buflomedil 

Pholcodine-containing medicines

Press release: European Medicines Agency confirms positive benefit-risk balance of pholcodine-containing cough medicines

pholcodine 


Safety update

Name of medicineINNMarketing authorisation holder
PradaxadabigatanBoehringer Ingelheim International GmbH


Other updates

Opinions on annual re-assessments and renewals
Opinions on safety variations
Start of Community reviews
Medicines granted a Community marketing authorisation under the centralised procedure since the October CHMP meeting
Scientific advice and protocol assistance
Guidelines and concept papers adopted during the November 2011 CHMP meeting
Organisational matters
Procedural announcements

How useful is this page?

Average rating:

 Based on 3 ratings

Add your rating:

See all ratings
1 ratings
0 ratings
0 ratings
1 ratings
1 ratings

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