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

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16/12/2011

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 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
EsmyaulipristalPregLem France SAS
VepacelA/H5N1 pre-pandemic influenza vaccine (whole virion, vero cell derived, inactivated)Baxter Innovations GmbH

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
Galvus  Jalra  XiliarxvildagliptinNovartis Europharm Ltd
Procoralan  CorlentorivabradineLes 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

Somatropin-containing medicines

 

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

somatropin 


Final opinion on arbitration procedure

Name of medicineINN
Norditropinsomatropin 


Other updates

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

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Related information

Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore users are asked to check the page regularly.

Contact point:

Monika Benstetter or
Sabine Haubenreisser
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu