- Home
- News and Events
- News and press release archive
News
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 medicine | INN | Marketing authorisation applicant |
|---|---|---|
| Docetaxel Accord | docetaxel | Accord Healthcare Ltd |
| Docetaxel Kabi | docetaxel | Fresenius Kabi Oncology Plc |
| Zoledronic Acid Teva Pharma | zoledronic acid | Teva Pharma B.V. |
| Zoledronic Acid Teva | zoledronic acid | Teva Pharma B.V. |
Positive opinions on extensions of therapeutic indications
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Menveo | meningococcal group A, C, W135 and Y conjugate vaccine | Novartis Vaccines and Diagnostics S.r.l. |
| Proquad | 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 |
|---|---|---|
| Femara and associated names | letrozole | Novartis group of companies |
| Priorix and associated names | 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 |
|---|---|---|
| Protelos/Osseor | 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 Caelyx and Ceplene |
| Ixiaro |
Other updates
How useful is this page?
Average rating:
Based on 1 ratingsAdd your rating:
- See all ratings
-
0 ratings0 ratings1 ratings0 ratings0 ratings
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