Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 2011
News
Human
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.
Name of medicine | INN | Marketing authorisation applicant |
---|---|---|
CHMP summary of positive opinion for Ameluz | 5-aminolevulinic acid | Biofrontera Bioscience GmbH |
Name of medicine | INN | Marketing authorisation applicant |
---|---|---|
CHMP summary of positive opinion for Efavirenz Tenz | efavirenz | Teva Pharma B.V. |
CHMP summary of positive opinion for Levetiracetam Sun | levetiracetam | Sun Pharmaceutical Industries Europe B.V. |
CHMP summary of positive opinion for Repaglinide Accord | repaglinide | Accord Healthcare Ltd |
CHMP summary of positive opinion for Topotecan Eagle | topotecan | Eagle Laboratories Ltd |
Name of medicine | INN | Marketing authorisation applicant |
---|---|---|
CHMP summary of positive opinion for Bronchitol
|
mannitol | Pharmaxis Pharmaceuticals Ltd |
Questions and answers on the refusal of the marketing authorisation for Glybera - Outcome of re-examination | alipogene tiparvovec | Amsterdam Molecular Therapeutics B.V. |
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
CHMP post-authorisation summary of positive opinion for Cervarix | human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed) | GlaxoSmithKline Biologicals S.A. |
CHMP post-authorisation summary of positive opinion for Onglyza | saxagliptin | Bristol-Myers Squibb / AstraZeneca EEIG |
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
Piogiltazone-containing medicines | pioglitazone | Takeda Global R&D Centre (Europe) Ltd |
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
Priligy | dapoxetine | Janssen-Cilag AB |
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
Protelos / Osseor | strontium ranelate | Les Laboratoires Servier |
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
Non-steroidal anti-inflammatory drugs (NSAIDs) |
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
Advagraf | tacrolimus | Astellas Pharma Europe B.V. |