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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 April 2012
London, UK (April 20, 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.
Positive opinions on new medicines
|
Name of medicine |
INN |
Marketing authorisation applicant |
|
Forxiga |
dapagliflozin |
Bristol-Myers Squibb / AstraZeneca EEIG |
|
ruxolitinib |
Novartis Europharm Ltd |
|
|
ferumoxytol |
Takeda Global Research and Development Centre (Europe) Ltd |
Final opinion on re-examination
|
Name of medicine |
INN |
Marketing authorisation applicant |
|
alipogene tiparvovec |
Amsterdam Molecular Therapeutics B.V. |
|
|
pralatrexate |
Allos Therapeutics Ltd |
Positive opinions on extensions of therapeutic indications
|
Name of medicine |
INN |
Marketing authorisation holder |
|
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 |
|
fluticasone propionate, formoterol fumarate |
Napp Pharmaceuticals Ltd |
|
|
ethinylestradiol / drospirenone |
Bayer PLC |
|
|
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 |
|
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 |
European Medicines Agency, 20.04.2012 (tB).