Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2011

16 December 2011

This page lists the opinions adopted at the December 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 Esmya	ulipristal	PregLem France SAS
CHMP summary of positive opinion for Vepacel	A/H5N1 pre-pandemic influenza vaccine (whole virion, vero cell derived, inactivated)	Baxter Innovations GmbH
CHMP summary of positive opinion for Zelboraf   Press release: European Medicines Agency recommends approval of first-in-class treatment for metastatic or unresectable melanoma	vemurafenib	Roche Registration Ltd

Positive opinions on extensions of therapeutic indications

Name of medicine	INN	Marketing authorisation holder
CHMP post-authorisation summary of positive opinion for GalvusCHMP post-authorisation summary of positive opinion for JalraCHMP post-authorisation summary of positive opinion for Xiliarx	vildagliptin	Novartis Europharm Ltd
CHMP post-authorisation positive summary of opinion for ProcoralanCHMP post-authorisation positive summary of opinion for Corlentor	ivabradine	Les Laboratoires Servier

Positive opinion on other changes to the marketing authorisation

Name of medicine	INN	Marketing authorisation holder
Vimpat	lacosamide	UCB Pharma SA

Final opinion on safety reviews for centrally and non-centrally authorised medicines

Name of medicine	INN
Questions and answers on the review of somatropin-containing medicines   Press release: European Medicines Agency confirms positive benefit-risk balance of somatropin-containing medicines	somatropin

Final opinion on arbitration procedure

Name of medicine	INN
Norditropin	somatropin

Other updates

Opinions on annual reassessments, 5-year renewals - Adopted at the CHMP meeting of 12-15 December 2011

Opinions on safety variations adopted at the CHMP meeting of 12-15 December 2011

Start of community reviews - CHMP meeting of 12-15 December 2011

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

Overview of invented names reviewed in November 2011 by the Name Review Group (NRG)

Scientific advice and protocol assistance adopted during the CHMP meeting 12-15 December 2011

Guidelines and concept papers adopted during the CHMP meeting 12-15 December 2011

Organisational matters, CHMP meeting 12-15 December 2011