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

News 18/11/2011

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
PDF icon Caprelsa vandetanibAstraZeneca AB


Positive opinions on generics

Name of medicineINNMarketing authorisation applicant
PDF icon Desloratadine Actavis desloratadineActavis Group PTC ehf
PDF icon Desloratadine ratiopharm desloratadineRatiopharm GmbH
PDF icon Docetaxel Mylan docetaxelMylan S.A.S.


Opinions on re-examination procedures for new medicines

Name of medicineINNMarketing authorisation applicant
PDF icon Sumatriptan Galpharm sumatriptanGalpharm Healthcare Ltd


Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
PDF icon Erbitux cetuximabMerck KGaA
PDF icon Herceptin trastuzumabRoche Registration Ltd
PDF icon Nevanac nepafenacAlcon Laboratories (UK) Ltd
PDF icon Rebif interferon beta-1aMerck Serono Europe Ltd


Opinions on re-examination procedures

Name of medicineINNMarketing authorisation holder
PDF icon Ariclaim, Cymbalta, Xeristar duloxetineEli 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

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

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