Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 March 2012
NewsHuman
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 |
|---|---|---|
| CHMP summary of positive opinion for Docetaxel Accord | docetaxel | Accord Healthcare Ltd |
| CHMP summary of positive opinion for Docetaxel Kabi | docetaxel | Fresenius Kabi Oncology Plc |
| zoledronic acid | Teva Pharma B.V. | |
| CHMP summary of positive opinion for Zoledronic acid Teva | zoledronic acid | Teva Pharma B.V. |
Positive opinions on extensions of therapeutic indications
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| CHMP post-authorisation summary of positive opinion for 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 |
|---|---|---|
| Questions and answers on the outcome of extension of indication application for Kogenate Bayer and Helixate Nexgen (octocog alfa) | 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 |
| Questions and answers on the review of Ixiaro (Japanese encephalitis vaccine) |