Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 2011
This page lists the opinions adopted at the September 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 for new medicines
Name of medicine | INN | Marketing authorisation applicant |
---|---|---|
Press release: European Medicines Agency recommends authorisation of novel antibiotic agent | fidaxomicin | FGK Representative Service GmbH |
| azilsartan medoxomil | Takeda Global Research and Development Centre (Europe) Ltd |
| azilsartan medoxomil | Takeda Global Research and Development Centre (Europe) Ltd |
| saxagliptin / metformin | Bristol-Myers Squibb / AstraZeneca EEIG |
| telmisartan / amlodipine | Boehringer Ingelheim International GmbH |
| aliskiren / amlodipine / hydrochlorothiazide | Novartis Europharm Ltd |
| rilpivirine | Janssen-Cilag International N.V. |
| emtricitabine / rilpivirine / tenofovir disoproxil | Gilead Sciences International Ltd |
Positive opinions for generics
Name of medicine | INN | Marketing authorisation applicant |
---|---|---|
| desloratadine | Krka, d.d., Novo mesto |
| desloratadine | Krka, d.d., Novo mesto |
| desloratadine | Teva Pharma B.V. |
| levetiracetam | Actavis Group PTC ehf |
| pioglitazone | Actavis Group PTC ehf |
| pioglitazone | Actavis Group PTC ehf |
| pioglitazone | Teva Pharma B.V. |
| pioglitazone | Teva Pharma B.V. |
| pioglitazone | Teva Generics B.V. |
| pioglitazone | Vaia S.A. |
Positive opinions for extensions of therapeutic indications
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
| pemetrexed | Eli Lilly Nederland B.V. |
| bevacizumab | Roche Registration Ltd |
| insulin detemir | Novo Nordisk A/S |
| pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) | Wyeth Lederle Vaccines S.A. |
| eculizumab | Alexion Europe SAS |
| rivaroxaban | Bayer Schering Pharma AG |
Final opinions on other variations
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
| liraglutide | Novo Nordisk A/S |
Final opinions on safety reviews for centrally authorised medicines
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
Multaq | dronedarone | Sanofi-aventis |
Revlimid | lenalidomide | Celgene Europe Ltd |
Vimpat syrup 15 mg/ml | lacosamide | UCB Pharma SA |
Final opinions on safety reviews for non-centrally authorised medicines
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
Dialysis solutions produced at Castlebar | Baxter group of companies and associated companies | |
Suppositories containing terpenic derivatives | camphor, cincole, pine / essential oil of pine needle, essential oil of eucalyptus, terpine, niaouli, essential oil of turpentine, terpineol, wild thyme |
Product shortages
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
| insulin glulisine | Sanofi-aventis Deutschland GmbH |
Other press releases
Other updates
Opinions on annual re-assessments and renewals
Scientific advice and protocol assistance
Guidelines and concept papers adopted during the September 2011 CHMP meeting