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

News 21/10/2011

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
PDF icon Ameluz 5-aminolevulinic acidBiofrontera Bioscience GmbH


Positive opinions on generics

Name of medicineINNMarketing authorisation applicant
PDF icon Efavirenz Teva efavirenzTeva Pharma B.V.
PDF icon Levetiracetam Sun levetiracetamSun Pharmaceutical Industries Europe B.V.
PDF icon Repaglinide Accord repaglinideAccord Healthcare Ltd
PDF icon Topotecan Eagle topotecanEagle Laboratories Ltd


Opinions on re-examination procedures for new medicines

Name of medicineINNMarketing authorisation applicant

PDF icon Bronchitol

mannitolPharmaxis Pharmaceuticals Ltd
PDF icon Glybera alipogene tiparvovecAmsterdam Molcular Therapeutics B.V.


Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
PDF icon Cervarix human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)GlaxoSmithKline Biologicals S.A.
PDF icon Onglyza saxagliptinBristol-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

PDF icon Opinions on annual re-assessments and renewals
PDF icon Opinions on safety variations
PDF icon Start of Community reviews
PDF icon Medicines granted a Community marketing authorisation under the centralised procedure since the September CHMP meeting
PDF icon Overview of invented names reviewed in September 2011
PDF icon Scientific advice and protocol assistance
PDF icon Guidelines and concept papers adopted during the October 2011 CHMP meeting
PDF icon Organisational matters
PDF icon Procedural announcements

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