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 medicineInternational non-proprietary name (INN)Marketing authorisation applicant
CHMP summary of positive opinion for Nimenrixmeningococcal group A, C, W-135 and Y conjugate vaccineGlaxoSmithKline Biologicals S.A.

CHMP summary of positive opinion for Pixuvri

 

Press release: European Medicines Agency recommends conditional approval of Pixuvri (pixantrone) for relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma

pixantrone dimaleateCTI Life Sciences Ltd

 

 

 

Press release: European Medicines Agency recommends new anti-malaria treatment for use outside the European Union

pyronaridine / artesunateShin Poong Pharmaceutical Co., Ltd
CHMP summary of positive opinion for SancusogranisetronProStrakan Ltd

Positive opinions on generics

Name of medicineINNMarketing authorisation applicant
CHMP summary of positive opinion for Capecitabine AccordcapecitabineAccord Healthcare Ltd
CHMP summary of positive opinion for Capecitabine KrkacapecitabineKrka, d.d., Novo mesto
CHMP summary of positive opinion for Capecitabine TevacapecitabineTeva Pharma B.V.
CHMP summary of positive opinion for SabervelirbesartanPharmathen S.A.
CHMP summary of positive opinion for Zoledronic acid Actaviszoledronic acidActavis Group PTC ehf

Positive opinion on informed consent application

Name of medicineINNMarketing authorisation holder
CHMP summary of positive opinion for Riluzole ZentivariluzoleAventis Pharma S.A.

Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
CHMP post-authorisation summary of positive opinion for ByettaexenatideEli Lilly Nederland B.V.
CHMP post-authorisation summary of positive opinion for HumiraadalimumabAbbott Laboratories Ltd
CHMP post authorisation summary of positive opinion for Pegintronpeginterferon alfa-2bSchering-Plough Europa
CHMP post-authorisation summary of positive opinion for RebetolribavirinSchering-Plough Europa
peginterferon alfa-2bSchering-Plough Europa

Final opinions on safety reviews for centrally authorised medicines

Name of medicineINNMarketing 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 medicineINN
Anti-tuberculosis medicines used in childrenisoniazide, rifampicine, pyrazinamide, ethambutol, rifabutin
Antifibrinolytic medicinesaprotinin, aminocaproic acid, tranexamic acid
Vivaglobinhuman normal immunoglobulin solution for injection (subcutaneous use)
Orlistat-containing medicines
Xenical, Alli, generics
orlistat

Safety update

Name of medicineINNMarketing authorisation holder
VictrelisboceprevirMerck Sharp & Dohme

CHMP recommendation on medication errors

Name of medicineINNMarketing authorisation holder
Questions and answers on the expression of the strength for Halaven (eribulin)eribulinEisai Europe Ltd

Other updates

Contact point

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