Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2011
This page lists the opinions adopted at the December 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 medicine | INN | Marketing authorisation applicant |
|---|---|---|
Esmya
| ulipristal | PregLem France SAS |
|
Vepacel
| A/H5N1 pre-pandemic influenza vaccine (whole virion, vero cell derived, inactivated) | Baxter Innovations GmbH |
| vemurafenib | Roche Registration Ltd |
Positive opinions on extensions of therapeutic indications
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
|
Galvus
Jalra
Xiliarx
| vildagliptin | Novartis Europharm Ltd |
|
Procoralan
Corlentor
| ivabradine | Les Laboratoires Servier |
Positive opinion on other changes to the marketing authorisation
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Vimpat | lacosamide | UCB Pharma SA |
Final opinion on safety reviews for centrally and non-centrally authorised medicines
| Name of medicine | INN |
|---|---|
| somatropin |
Final opinion on arbitration procedure
| Name of medicine | INN |
|---|---|
| Norditropin | somatropin |