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EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 January 2012
London, UK (January 20, 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 |
pasireotide |
Novartis Europharm Ltd |
Negative opinion on new medicine
Name of medicine |
INN |
Marketing authorisation applicant |
pralatrexate |
Allos Therapeutics Ltd |
Positive opinions on extensions of therapeutic indications
Name of medicine |
INN |
Marketing authorisation holder |
infliximab |
Janssen Biologics B.V. |
|
rotavirus vaccine |
Sanofi Pasteur MSD |
Final opinion on safety reviews for non-centrally authorised medicines
Name of medicine |
Meprobamate-containing medicines |
Other CHMP recommendation on safety issues
Name of medicine |
INN |
Marketing authorisation holder |
Gilenya |
fingolimod |
Novartis Europharm Ltd |
CHMP recommendation on medication errors
Name of medicine |
INN |
Marketing authorisation holder |
bortezomib |
Janssen-Cilag International N.V. |
Other updates
Opinions on consultation procedures on ancillary medicinal substances in medical devices |
Opinions on annual re-assessments and renewals |
European Medicines Agency (EMA), 20.01.2012 (tB).