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 medicine	INN	Marketing authorisation applicant
Caprelsa	vandetanib	AstraZeneca AB

Positive opinions on generics

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

Opinions on re-examination procedures for new medicines

Name of medicine	INN	Marketing authorisation applicant
Sumatriptan Galpharm	sumatriptan	Galpharm Healthcare Ltd

Positive opinions on extensions of therapeutic indications

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

Opinions on re-examination procedures

Name of medicine	INN	Marketing authorisation holder
Ariclaim, Cymbalta, Xeristar	duloxetine	Eli Lilly Nederland B.V.

Final opinions on safety reviews for non-centrally authorised medicines

Safety update

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