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 iconCaprelsa vandetanibAstraZeneca AB


Positive opinions on generics

Name of medicineINNMarketing authorisation applicant
PDF iconDesloratadine Actavis desloratadineActavis Group PTC ehf
PDF iconDesloratadine ratiopharm desloratadineRatiopharm GmbH
PDF iconDocetaxel Mylan docetaxelMylan S.A.S.


Opinions on re-examination procedures for new medicines

Name of medicineINNMarketing authorisation applicant
PDF iconSumatriptan Galpharm sumatriptanGalpharm Healthcare Ltd


Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
PDF iconErbitux cetuximabMerck KGaA
PDF iconHerceptin trastuzumabRoche Registration Ltd
PDF iconNevanac nepafenacAlcon Laboratories (UK) Ltd
PDF iconRebif interferon beta-1aMerck Serono Europe Ltd


Opinions on re-examination procedures

Name of medicineINNMarketing authorisation holder
PDF iconAriclaim, 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 iconOpinions on annual re-assessments and renewals
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconMedicines granted a Community marketing authorisation under the centralised procedure since the October CHMP meeting
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted during the November 2011 CHMP meeting
PDF iconOrganisational matters
Procedural announcements

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