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20/04/2012
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 April 2012
This page lists the opinions adopted at the April 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 has gathered feedback from journalists and other stakeholders. It will make some changes to the format by May 2012.
Positive opinions on new medicines
| Name of medicine | INN | Marketing authorisation applicant |
|---|---|---|
| Forxiga Press release: European Medicines Agency recommends authorisation of novel treatment for type 2 diabetes | dapagliflozin | Bristol-Myers Squibb / AstraZeneca EEIG |
| Jakavi | ruxolitinib | Novartis Europharm Ltd |
| Rienso | ferumoxytol | Takeda Global Research and Development Centre (Europe) Ltd |
Final opinions on re-examinations
| Name of medicine | INN | Marketing authorisation applicant |
|---|---|---|
| Glybera Press release: European medicines Agency maintains recommendation not to grant a marketing authorisation for Glybera | alipogene tiparvovec | Amsterdam Molecular Therapeutics B.V. |
| Folotyn | pralatrexate | Allos Therapeutics Ltd |
Positive opinions on extensions of therapeutic indications
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Optisulin / Lantus | insulin glargine | Sanofi-aventis Deutschland GmbH |
Final opinions on safety reviews of centrally authorised medicines
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| fingolimod | Novartis Europharm Ltd |
Final opinions on arbitration procedures
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Flutiform / Iffeza | fluticasone propionate / formoterol fumarate | Napp Pharmaceuticals Ltd |
| Yaz 24+4 / Ethinylestradiol-Drospirenone 24+4 | ethinylestradiol / drospirenone | Bayer PLC |
| Yvidually | ethinylestradiol / drospirenone | Bayer B.V. |
Other updates
| Opinions on annual re-assessments and renewals |
| Opinions on safety variations |
| Medicines granted a Community marketing authorisation under the centralised procedure from 1-31 March 2012 |
| Scientific advice and protocol assistance |
| Guidelines and concept papers adopted during the April 2012 CHMP meeting |
| Overview of invented names reviewed in March 2012 by the Name Review Group (NRG) |
| Organisational matters |
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Related information
- Flutiform: Article 29 referral
- Iffeza: Article 29 referral
- Yaz 24+4: Article 6(12) referral
- Ethinylestradiol-Drospirenone 24+4: Article 6(12) referral
- Yvidually: Article 29 referral
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