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

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

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.

Other updates

Share this page