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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
12-15 March 2012
London, UK (March 16, 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 medicine |
INN |
Marketing authorisation applicant |
|
docetaxel |
Accord Healthcare Ltd |
|
|
docetaxel |
Fresenius Kabi Oncology Plc |
|
|
zoledronic acid |
Teva Pharma B.V. |
|
|
zoledronic acid |
Teva Pharma B.V. |
Positive opinions on extensions of therapeutic indications
|
Name of medicine |
INN |
Marketing authorisation holder |
|
meningococcal group A, C, W135 and Y conjugate vaccine |
Novartis Vaccines and Diagnostics S. r.l. |
|
|
measles, mumps, rubella and varicella vaccine |
Sanofi Pasteur MSD |
Final opinion on other variations
|
Name of medicine |
INN |
Marketing authorisation holder |
|
Helixate NexGen / Kogenate Bayer |
octocog alfa |
Bayer Pharma AG |
Final opinions on harmonisation referrals
|
Name of medicine |
INN |
Marketing authorisation holder |
|
letrozole |
Novartis group of companies |
|
|
live attenuated measles, mumps and rubella virus |
GSK group of companies |
Final opinions on safety reviews of centrally authorised medicines
|
Name of medicine |
INN |
Marketing authorisation holder |
|
strontium ranelate |
Les Laboratoires Servier |
Final opinions on reviews of centrally authorised medicines related to manufacturing issues
|
Name of medicine |
|
Medicines manufactured at Ben Venue Laboratories |
Other updates
|
Opinions on annual re-assessments and renewals |
|
Opinions on safety variations |
|
Medicines granted a Community marketing authorisation under the centralised procedure since the January CHMP meeting |
|
Guidelines and concept papers adopted during the March 2012 CHMP meeting |
|
European Union recommendations for virus strains in seasonal influenza vaccines 2012-2013 |
Quelle: European Medicines Agency, 16.03.2012 (tB).