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Meeting highlights from the Committee for Human Medicinal Products (CHMP) 13-16 February 2012
London, UK (February 17, 2012) – This page lists the opinions adopted at the February 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 |
Meningococcal Group A, C, W-135 and Y conjugate vaccine |
GlaxoSmithKline Biologicals S.A. |
|
Pixantrone Dimaleate |
CTI Life Sciences Ltd |
|
Pyronaridine / Artesunate |
Shin Poong Pharmaceutical Co., Ltd |
|
Granisetron |
ProStrakan Ltd |
Positive opinions on generics
Name of medicine |
INN |
Marketing authorisation applicant |
Capecitabine |
Accord Healthcare Ltd |
|
Capecitabine |
Krka, d.d., Novo mesto |
|
Capecitabine |
Teva Pharma B.V. |
|
Irbesartan |
Pharmathen S.A. |
|
Zoledronic Acid |
Actavis Group PTC ehf |
Positive opinion on informed consent application
Name of medicine |
INN |
Marketing authorisation holder |
Riluzole |
Pharma S.A. |
Positive opinions on extensions of therapeutic indications
Name of medicine |
INN |
Marketing authorisation holder |
Exenatide |
Eli Lilly Nederland B.V. |
|
Adalimumab |
Abbott Laboratories Ltd |
|
Peginterferon alfa-2b |
Schering-Plough Europa |
|
Ribavirin |
Schering-Plough Europa |
|
Peginterferon alfa-2b |
Schering-Plough Europa |
Final opinions on safety reviews for centrally authorised medicines
Name of medicine |
INN |
Marketing authorisation holder |
Aliskiren-containing medicines |
aliskiren |
Novartis Europharm Ltd |
Final opinions on reviews for centrally and non-centrally authorised medicines relating to manufacturing issues
Name of medicine |
Medicines manufactured at Ben Venu Laboratories |
Final opinions on safety reviews for centrally and non-centrally authorised medicines
Name of medicine |
INN |
isoniazide, rifampicine, pyrazinamide, ethambutol, rifabutin |
|
Antifibrinolytics containing medicines Press release: European Medicines Agency recommends lifting suspension of aprotinin |
aprotinin, aminocaproic acid or tranexamic acid |
human normal immunoglobulin solution for injection (subcutaneous use) |
|
Orlistat-containing medicines |
orlistat |
Safety update
Name of medicine |
INN |
Marketing authorisation holder |
Boceprevir |
Merck Sharp & Dohme |
CHMP recommendation on medication errors
Name of medicine |
INN |
Marketing authorisation holder |
Eribulin |
Eisai Europe Ltd |
Other updates
Opinions on consultation procedures on ancillary medicinal substances in medicinal devices |
Opinions on annual re-assessments and renewals |
Opinions on safety variations |
Overview of invented names reviewed in January 2012 by the Name Review Group (NRG) |
Guidelines and concept papers adopted during the February 2012 CHMP meeting |
Organisational matters |
European Medicines Agency, 17.02.2012 (tB).