Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 January 2012
News
Human
Medicines
This page lists the opinions adopted at the January 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 is gathering feedback from journalists and other stakeholders. It will make any necessary changes to the format in early 2012.
Positive opinion on new medicine
| Name of medicine | INN | Marketing authorisation applicant |
|---|---|---|
| CHMP summary of positive opinion for Signifor
Press release: European Medicines Agency recommends approval of new medicine for Cushing's disease |
pasireotide | Novartis Europharm Ltd |
Negative opinion on new medicine
| Name of medicine | INN | Marketing authorisation applicant |
|---|---|---|
| Questions and answers on the refusal of the marketing authorisation for Folotyn | pralatrexate | Allos Therapeutics Ltd |
Positive opinions on extensions of therapeutic indications
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| CHMP post-authorisation summary of positive opinion for Remicade | infliximab | Janssen Biologics B.V. |
| CHMP post-authorisation summary of positive opinion for RotaTeq | rotavirus vaccine | Sanofi Pasteur MSD |
Final opinion on safety reviews for non-centrally authorised medicines
Other CHMP recommendation on safety issues
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Questions and answers on the ongoing review of Gilenya (fingolimod)
Press release: European Medicines Agency starts review of Gilenya (fingolimod) |
fingolimod | Novartis Europharm Ltd |
CHMP recommendation on medication errors
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Velcade: questions and answers on recommendations to prevent administration errors | bortezomib | Janssen-Cilag International N.V. |