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

18 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 medicine	INN	Marketing authorisation applicant
CHMP summary of positive opinion for Caprelsa	vandetanib	AstraZeneca AB

Positive opinions on generics

Name of medicine	INN	Marketing authorisation applicant
CHMP summary of positive opinion for Desloratadine Actavis	desloratadine	Actavis Group PTC ehf
CHMP summary of positive opinion for Desloratadine ratiopharm	desloratadine	Ratiopharm GmbH
CHMP summary of positive opinion for Docetaxel Mylan	docetaxel	Mylan S.A.S.

Opinions on re-examination procedures for new medicines

Name of medicine	INN	Marketing authorisation applicant
Questions and answers on the refusal of the marketing authorisation for Sumatriptan Galpharm 50 mg tablets - Outcome of re-examination	sumatriptan	Galpharm Healthcare Ltd

Positive opinions on extensions of therapeutic indications

Name of medicine	INN	Marketing authorisation holder
CHMP post-authorisation summary of positive opinion for Erbitux	cetuximab	Merck KGaA
CHMP post-authorisation summary of positive opinion for Herceptin	trastuzumab	Roche Registration Ltd
CHMP post-authorisation summary of positive opinion for Nevanac	nepafenac	Alcon Laboratories (UK) Ltd
CHMP post-authorisation summary of positive opinion for Rebif	interferon beta-1a	Merck Serono Europe Ltd

Opinions on re-examination procedures

Name of medicine	INN	Marketing authorisation holder
Questions and answers on the refusal of a change to the marketing authorisations for Ariclaim, Cymbalta and Xeristar (duloxetine) - Outcome of re-examination	duloxetine	Eli Lilly Nederland B.V.

Final opinions on safety reviews for non-centrally authorised medicines

Name of medicine	INN
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 medicine	INN	Marketing authorisation holder
Pradaxa	dabigatan	Boehringer Ingelheim International GmbH

Other updates

Opinions on annual reassessments, 5-year renewals adopted at the CHMP meeting of 14-17 November 2011

Opinions on safety variations adopted at the CHMP meeting of 14-17 November 2011

Start of community reviews, CHMP meeting of 14-17 November 2011

Medicines granted a Community marketing authorisation under the centralised procedure since the October CHMP meeting

Scientific advice and protocol assistance adopted during the CHMP meeting 14-17 November 2011

Guidelines and concept papers adopted during the CHMP meeting 14-17 November 2011

Organisational matters - CHMP meeting 14-17 November 2011

Procedural announcements - CHMP meeting 14-17 November 2011