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.
The Agency is gathering feedback from journalists and other stakeholders. It will make any necessary changes to the format in early 2012.
Positive opinions on new medicines
Name of medicine | International non-proprietary name (INN) | Marketing authorisation applicant |
---|---|---|
CHMP summary of positive opinion for Nimenrix | meningococcal group A, C, W-135 and Y conjugate vaccine | GlaxoSmithKline Biologicals S.A. |
CHMP summary of positive opinion for Pixuvri
| pixantrone dimaleate | CTI Life Sciences Ltd |
| pyronaridine / artesunate | Shin Poong Pharmaceutical Co., Ltd |
CHMP summary of positive opinion for Sancuso | granisetron | ProStrakan Ltd |
Positive opinions on generics
Name of medicine | INN | Marketing authorisation applicant |
---|---|---|
CHMP summary of positive opinion for Capecitabine Accord | capecitabine | Accord Healthcare Ltd |
CHMP summary of positive opinion for Capecitabine Krka | capecitabine | Krka, d.d., Novo mesto |
CHMP summary of positive opinion for Capecitabine Teva | capecitabine | Teva Pharma B.V. |
CHMP summary of positive opinion for Sabervel | irbesartan | Pharmathen S.A. |
CHMP summary of positive opinion for Zoledronic acid Actavis | zoledronic acid | Actavis Group PTC ehf |
Positive opinion on informed consent application
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
CHMP summary of positive opinion for Riluzole Zentiva | riluzole | Aventis Pharma S.A. |
Positive opinions on extensions of therapeutic indications
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
CHMP post-authorisation summary of positive opinion for Byetta | exenatide | Eli Lilly Nederland B.V. |
CHMP post-authorisation summary of positive opinion for Humira | adalimumab | Abbott Laboratories Ltd |
CHMP post authorisation summary of positive opinion for Pegintron | peginterferon alfa-2b | Schering-Plough Europa |
CHMP post-authorisation summary of positive opinion for Rebetol | 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 Razilez, Riprazo, Sprimeo, Rasilamlo, Rasilez HCT, Riprazo HCT, Sprimeo HCT, Rasitrio | aliskiren
| Novartis Europharm Ltd
|
Final opinions on reviews for centrally authorised medicines relating to manufacturing issues
Name of medicine |
---|
Medicines manufactured at Ben Venue Laboratories Angiox, Busilvex, Cayston, Ecalta, Luminity, Mepact, Soliris, Torisel, Velcade, Vibativ, Vidaza, Vistide |
Final opinions on safety reviews for centrally and non-centrally authorised medicines
Name of medicine | INN |
---|---|
Anti-tuberculosis medicines used in children | isoniazide, rifampicine, pyrazinamide, ethambutol, rifabutin |
Antifibrinolytic medicines | aprotinin, aminocaproic acid, tranexamic acid |
Vivaglobin | human normal immunoglobulin solution for injection (subcutaneous use) |
Orlistat-containing medicines Xenical, Alli, generics | orlistat |
Safety update
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
Victrelis | boceprevir | Merck Sharp & Dohme |
CHMP recommendation on medication errors
Name of medicine | INN | Marketing authorisation holder |
---|---|---|
Questions and answers on the expression of the strength for Halaven (eribulin) | eribulin | Eisai Europe Ltd |