This page lists the opinions adopted at the November 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 medicine | INN | Marketing authorisation applicant |
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Caprelsa
| vandetanib | AstraZeneca AB |
Positive opinions on generics
Opinions on re-examination procedures for new medicines
Name of medicine | INN | Marketing authorisation applicant |
---|
Sumatriptan Galpharm
| sumatriptan | Galpharm Healthcare Ltd |
Positive opinions on extensions of therapeutic indications
Name of medicine | INN | Marketing authorisation holder |
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Erbitux
| cetuximab | Merck KGaA |
Herceptin
| trastuzumab | Roche Registration Ltd |
Nevanac
| nepafenac | Alcon Laboratories (UK) Ltd |
Rebif
| interferon beta-1a | Merck Serono Europe Ltd |
Opinions on re-examination procedures
Final opinions on safety reviews for non-centrally authorised medicines
Safety update
Name of medicine | INN | Marketing authorisation holder |
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Pradaxa | dabigatan | Boehringer Ingelheim International GmbH |
Other updates