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

News 17/02/2012

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
PDF icon Nimenrix meningococcal group A, C, W-135 and Y conjugate vaccineGlaxoSmithKline Biologicals S.A.

PDF icon 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
PDF icon Sancuso granisetronProStrakan Ltd

Positive opinions on generics

Name of medicineINNMarketing authorisation applicant
PDF icon Capecitabine Accord capecitabineAccord Healthcare Ltd
PDF icon Capecitabine Krka capecitabineKrka, d.d., Novo mesto
PDF icon Capecitabine Teva capecitabineTeva Pharma B.V.
PDF icon Sabervel irbesartanPharmathen S.A.
PDF icon Zoledronic Acid Actavis zoledronic acidActavis Group PTC ehf

Positive opinion on informed consent application

Name of medicineINNMarketing authorisation holder
PDF icon Riluzole Zentiva riluzoleAventis Pharma S.A.

Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
PDF icon Byetta exenatideEli Lilly Nederland B.V.
PDF icon Humira adalimumabAbbott Laboratories Ltd
PDF icon PegIntron peginterferon alfa-2bSchering-Plough Europa
PDF icon Rebetol ribavirinSchering-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



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

Safety update

Name of medicineINNMarketing authorisation holder
VictrelisboceprevirMerck Sharp & Dohme

CHMP recommendation on medication errors

Name of medicineINNMarketing authorisation holder
PDF icon Halaven eribulinEisai Europe Ltd

Other updates

PDF icon Opinions on consultation procedures on ancillary medicinal substances in medicinal devices
PDF icon Opinions on annual re-assessments and renewals
PDF icon Opinions on safety variations
PDF icon Start of Community reviews
PDF icon Medicines granted a Community marketing authorisation under the centralised procedure since the January CHMP meeting
PDF icon Overview of invented names reviewed in January 2012 by the Name Review Group (NRG)
PDF icon Scientific advice and protocol assistance
PDF icon Guidelines and concept papers adopted during the February 2012 CHMP meeting
PDF icon Organisational matters

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