Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2011

News 16/12/2011

This page lists the opinions adopted at the December 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

Name of medicineINNMarketing authorisation applicant
PDF icon Esmya ulipristalPregLem France SAS
PDF icon Vepacel A/H5N1 pre-pandemic influenza vaccine (whole virion, vero cell derived, inactivated)Baxter Innovations GmbH

PDF icon Zelboraf


Press release: European Medicines Agency recommends approval of first-in-class treatment for metastatic or unresectable melanoma

vemurafenibRoche Registration Ltd

Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
PDF icon Galvus PDF icon Jalra PDF icon Xiliarx vildagliptinNovartis Europharm Ltd
PDF icon Procoralan PDF icon Corlentor ivabradineLes Laboratoires Servier

Positive opinion on other changes to the marketing authorisation

Name of medicineINNMarketing authorisation holder
VimpatlacosamideUCB Pharma SA

Final opinion on safety reviews for centrally and non-centrally authorised medicines

Name of medicineINN

PDF icon Somatropin-containing medicines


Press release: European Medicines Agency confirms positive benefit-risk balance of somatropin-containing medicines


Final opinion on arbitration procedure

Name of medicineINN

Other updates

PDF icon Opinions on annual re-assessments and renewals
PDF icon Opinions on safety variations
PDF icon Start of Community reviews
PDF icon Medicines granted a Community marketing authorisation under the centralised procedure since the November CHMP meeting
PDF icon Overview of invented names reviewed in November 2011
PDF icon Scientific advice and protocol assistance
PDF icon Guidelines and concept papers adopted during the December 2011 CHMP meeting
PDF icon Organisational matters

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