Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 2011

21 October 2011

This page lists the opinions adopted at the October 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 Ameluz	5-aminolevulinic acid	Biofrontera Bioscience GmbH

Positive opinions on generics

Name of medicine	INN	Marketing authorisation applicant
CHMP summary of positive opinion for Efavirenz Tenz	efavirenz	Teva Pharma B.V.
CHMP summary of positive opinion for Levetiracetam Sun	levetiracetam	Sun Pharmaceutical Industries Europe B.V.
CHMP summary of positive opinion for Repaglinide Accord	repaglinide	Accord Healthcare Ltd
CHMP summary of positive opinion for Topotecan Eagle	topotecan	Eagle Laboratories Ltd

Opinions on re-examination procedures for new medicines

Name of medicine	INN	Marketing authorisation applicant
CHMP summary of positive opinion for Bronchitol   Questions and answers on the positive opinion on the marketing authorisation for Bronchitol (mannitol)	mannitol	Pharmaxis Pharmaceuticals Ltd
Questions and answers on the refusal of the marketing authorisation for Glybera - Outcome of re-examination	alipogene tiparvovec	Amsterdam Molecular Therapeutics B.V.

Positive opinions on extensions of therapeutic indications

Name of medicine	INN	Marketing authorisation holder
CHMP post-authorisation summary of positive opinion for Cervarix	human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)	GlaxoSmithKline Biologicals S.A.
CHMP post-authorisation summary of positive opinion for Onglyza	saxagliptin	Bristol-Myers Squibb / AstraZeneca EEIG

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

Name of medicine	INN	Marketing authorisation holder
Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer   Press release: European Medicines Agency concludes that benefit-risk balance of angiotensin II receptor antagonists remains positive

Final opinions on safety reviews for centrally authorised medicines

Name of medicine	INN	Marketing authorisation holder
Piogiltazone-containing medicines	pioglitazone	Takeda Global R&D Centre (Europe) Ltd

Final opinion on arbitration procedure

Name of medicine	INN	Marketing authorisation holder
Priligy	dapoxetine	Janssen-Cilag AB

Start of safety review of centrally authorised medicines

Name of medicine	INN	Marketing authorisation holder
Protelos / Osseor	strontium ranelate	Les Laboratoires Servier

Start of safety review of non-centrally authorised medicines

Name of medicine	INN	Marketing authorisation holder
Non-steroidal anti-inflammatory drugs (NSAIDs)

Product recall

Name of medicine	INN	Marketing authorisation holder
Advagraf	tacrolimus	Astellas Pharma Europe B.V.

Other updates

Opinions on annual re-assessments and five-year renewals adopted at the Committee for Medicinal Products for Human Use meeting of 17-20 October 2011

Opinions on safety variations adopted at the Committee for Medicinal Products for Human Use meeting of 17-20 October 2011

Start of community reviews adopted at the Committee for Medicinal Products for Human Use meeting of 17-20 October 2011

Medicines granted a Community marketing authorisation under the centralised procedure since the Committee for Medicinal Products for Human Use meeting 19-22 September 2011

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

Scientific advice and protocol assistance adopted during the Committee for Medicinal Products for Human Use meeting 17-20 October 2011

Guidelines and concept papers adopted during the Committee for Medicinal Products for Human Use meeting 17-20 October 2011

Organisational matters: Committee for Medicinal Products for Human Use meeting 17-20 October 2011

Procedural announcements: Committee for Medicinal Products for Human Use meeting 17-20 October 2011