Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 March 2012

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16/03/2012

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 March 2012

This page lists the opinions adopted at the March 2012 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 has gathered feedback from journalists and other stakeholders. It will make some changes to the format by April 2012.


Positive opinions on generics

Name of medicineINNMarketing authorisation applicant
Docetaxel AccorddocetaxelAccord Healthcare Ltd
Docetaxel KabidocetaxelFresenius Kabi Oncology Plc
Zoledronic Acid Teva Pharmazoledronic acidTeva Pharma B.V.
Zoledronic Acid Tevazoledronic acidTeva Pharma B.V.


Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
Menveomeningococcal group A, C, W135 and Y conjugate vaccineNovartis Vaccines and Diagnostics S.r.l.
Proquadmeasles, mumps, rubella and varicella vaccineSanofi Pasteur MSD


Final opinion on other variations

Name of medicineINNMarketing authorisation holder
Helixate NexGen / Kogenate Bayeroctocog alfaBayer Pharma AG


Final opinions on harmonisation referrals

Name of medicineINNMarketing authorisation holder
Femara and associated namesletrozoleNovartis group of companies
Priorix and associated nameslive attenuated measles, mumps and rubella virusGSK group of companies


Final opinions on safety reviews of centrally authorised medicines

Name of medicineINNMarketing authorisation holder
Protelos/Osseorstrontium ranelateLes Laboratoires Servier


Final opinions on reviews of centrally authorised medicines related to manufacturing issues

Name of medicine
Medicines manufactured at Ben Venue Laboratories
Caelyx and Ceplene
Ixiaro


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 from 01 February to 29 February 2012
Scientific advice and protocol assistance
Guidelines and concept papers adopted during the March 2012 CHMP meeting
European Union recommendations for virus strains in seasonal influenza vaccines 2012-2013
Organisational matters
Procedural announcements

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