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

News 20/01/2012

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 medicineINNMarketing authorisation applicant
PDF iconSignifor

Press release: European Medicines Agency recommends approval of new medicine for Cushing's disease
pasireotideNovartis Europharm Ltd


Negative opinion on new medicine

Name of medicineINNMarketing authorisation applicant
PDF iconFolotyn pralatrexateAllos Therapeutics Ltd


Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
PDF iconRemicade infliximabJanssen Biologics B.V.
PDF iconRotaTeq rotavirus vaccineSanofi Pasteur MSD


Final opinion on safety reviews for non-centrally authorised medicines

Name of medicine
PDF iconMeprobamate-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 medicineINNMarketing authorisation holder
PDF iconGilenya

Press release: European Medicines Agency starts review of Gilenya (fingolimod)
fingolimodNovartis Europharm Ltd


CHMP recommendation on medication errors

Name of medicineINNMarketing authorisation holder
PDF iconVelcade bortezomibJanssen-Cilag International N.V.


Other updates

PDF iconOpinions on consultation procedures on ancillary medicinal substances in medical devices
PDF iconOpinions on annual re-assessments and renewals
PDF iconStart of Community reviews
Scientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted during the January 2011 CHMP meeting
PDF iconProcedural announcements
PDF iconOrganisational matters

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