Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 2012

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17/02/2012

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 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.

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
Nimenrixmeningococcal group A, C, W-135 and Y conjugate vaccineGlaxoSmithKline Biologicals S.A.

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

Pyramax

 

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

pyronaridine / artesunateShin Poong Pharmaceutical Co., Ltd
SancusogranisetronProStrakan Ltd


Positive opinions on generics

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


Positive opinion on informed consent application

Name of medicineINNMarketing authorisation holder
Riluzole ZentivariluzoleAventis Pharma S.A.


Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
ByettaexenatideEli Lilly Nederland B.V.
HumiraadalimumabAbbott Laboratories Ltd
PegIntronpeginterferon alfa-2bSchering-Plough Europa
RebetolribavirinSchering-Plough Europa
ViraferonPegpeginterferon 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
HalaveneribulinEisai 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
Start of Community reviews
Medicines granted a Community marketing authorisation under the centralised procedure since the January CHMP meeting
Overview of invented names reviewed in January 2012 by the Name Review Group (NRG)
Scientific advice and protocol assistance
Guidelines and concept papers adopted during the February 2012 CHMP meeting
Organisational matters

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Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore users are asked to check the page regularly.

Contact point:

Monika Benstetter or
Sabine Haubenreisser
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu