Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 January 2012

20 January 2012

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

Name of medicine
Questions and answers on the suspension of the marketing authorisations for oral meprobamate-containing medicines Press release: European Medicines Agency recommends suspension of marketing authorisations for meprobamate-containing medicines in the European Union

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.

Other updates

Opinions on consultation procedures on ancillary medicinal substances in medical devices adopted at the CHMP meeting of 16-19 January 2012

Opinions on annual reassessments, 5-year renewals adopted at the CHMP meeting of 16-19 January 2012

Start of community reviews adopted during the CHMP meeting of 16-19 January 2012

Scientific advice and protocol assistance adopted during the CHMP meeting 16-19 January 2012

Guidelines and concept papers adopted during the CHMP meeting 16-19 January 2012

Procedural announcements - CHMP meeting 16-19 January 2012

Organisational matters - CHMP meeting 16-19 January 2012