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21/10/2011
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 2011
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
| Name of medicine | INN | Marketing authorisation applicant |
|---|---|---|
| Ameluz | 5-aminolevulinic acid | Biofrontera Bioscience GmbH |
Positive opinions on generics
| Name of medicine | INN | Marketing authorisation applicant |
|---|---|---|
| Efavirenz Teva | efavirenz | Teva Pharma B.V. |
| Levetiracetam Sun | levetiracetam | Sun Pharmaceutical Industries Europe B.V. |
| Repaglinide Accord | repaglinide | Accord Healthcare Ltd |
| Topotecan Eagle | topotecan | Eagle Laboratories Ltd |
Opinions on re-examination procedures for new medicines
| Name of medicine | INN | Marketing authorisation applicant |
|---|---|---|
| mannitol | Pharmaxis Pharmaceuticals Ltd |
| Glybera | alipogene tiparvovec | Amsterdam Molcular Therapeutics B.V. |
Positive opinions on extensions of therapeutic indications
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Cervarix | human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed) | GlaxoSmithKline Biologicals S.A. |
| Onglyza | saxagliptin | Bristol-Myers Squibb / AstraZeneca EEIG |
Final opinions on safety reviews for centrally and non-centrally authorised medicines
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
Final opinions on safety reviews for centrally authorised medicines
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Piogiltazone-containing medicines | pioglitazone | Takeda Global R&D Centre (Europe) Ltd |
Final opinion on arbitration procedure
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Priligy | dapoxetine | Janssen-Cilag AB |
Start of safety review of centrally authorised medicines
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Protelos / Osseor | strontium ranelate | Les Laboratoires Servier |
Start of safety review of non-centrally authorised medicines
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Non-steroidal anti-inflammatory drugs (NSAIDs) |
Product recall
| Name of medicine | INN | Marketing authorisation holder |
|---|---|---|
| Advagraf | tacrolimus | Astellas Pharma Europe B.V. |
Other updates
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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