Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 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
Ameluz	5-aminolevulinic acid	Biofrontera Bioscience GmbH

Positive opinions on generics

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

Opinions on re-examination procedures for new medicines

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

Positive opinions on extensions of therapeutic indications

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

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

Final opinions on safety reviews for centrally authorised medicines

Final opinion on arbitration procedure

Start of safety review of centrally authorised medicines

Start of safety review of non-centrally authorised medicines

Product recall

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 September CHMP meeting

Overview of invented names reviewed in September 2011

Scientific advice and protocol assistance

Guidelines and concept papers adopted during the October 2011 CHMP meeting

Organisational matters

Procedural announcements