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

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21/10/2011

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 medicineINNMarketing authorisation applicant
Ameluz5-aminolevulinic acidBiofrontera Bioscience GmbH


Positive opinions on generics

Name of medicineINNMarketing authorisation applicant
Efavirenz TevaefavirenzTeva Pharma B.V.
Levetiracetam SunlevetiracetamSun Pharmaceutical Industries Europe B.V.
Repaglinide AccordrepaglinideAccord Healthcare Ltd
Topotecan EagletopotecanEagle Laboratories Ltd


Opinions on re-examination procedures for new medicines

Name of medicineINNMarketing authorisation applicant

Bronchitol

 

mannitolPharmaxis Pharmaceuticals Ltd
Glyberaalipogene tiparvovecAmsterdam Molcular Therapeutics B.V.


Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
Cervarixhuman papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)GlaxoSmithKline Biologicals S.A.
OnglyzasaxagliptinBristol-Myers Squibb / AstraZeneca EEIG


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

Name of medicineINNMarketing authorisation holder

Angiotensin II receptor antagonists

 

  


Final opinions on safety reviews for centrally authorised medicines

Name of medicineINNMarketing authorisation holder
Piogiltazone-containing medicinespioglitazoneTakeda Global R&D Centre (Europe) Ltd


Final opinion on arbitration procedure

Name of medicineINNMarketing authorisation holder
PriligydapoxetineJanssen-Cilag AB


Start of safety review of centrally authorised medicines

Name of medicineINNMarketing authorisation holder
Protelos / Osseorstrontium ranelateLes Laboratoires Servier


Start of safety review of non-centrally authorised medicines

Name of medicineINNMarketing authorisation holder
Non-steroidal anti-inflammatory drugs (NSAIDs)  


Product recall

Name of medicineINNMarketing authorisation holder
AdvagraftacrolimusAstellas Pharma Europe B.V.


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

Related information

Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore users are asked to check the page regularly.

Contact point:

Monika Benstetter or 
Sabine Haubenreisser
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu