This page lists the opinions adopted at the October 2011 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 over the first three months of publication. It will make any necessary changes to the format in early 2012.
Positive opinions on new medicines
Positive opinions on generics
Opinions on re-examination procedures for new medicines
Positive opinions on extensions of therapeutic indications
|Name of medicine||INN||Marketing authorisation holder|
||human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)||GlaxoSmithKline Biologicals S.A.|
||saxagliptin||Bristol-Myers Squibb / AstraZeneca EEIG|
Final opinions on safety reviews for centrally and non-centrally authorised medicines
Final opinions on safety reviews for centrally authorised medicines
Final opinion on arbitration procedure
Start of safety review of centrally authorised medicines
Start of safety review of non-centrally authorised medicines