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

17 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 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   Press release: European Medicines Agency recommends conditional approval of Pixuvri (pixantrone) for relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma	pixantrone dimaleate	CTI Life Sciences Ltd
Press release: European Medicines Agency recommends new anti-malaria treatment for use outside the European Union	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

Other updates

Opinions on consultation procedures on ancillary medicinal substances in medical devices adopted at the CHMP meeting of 13-16 February 2012

Opinions on annual re-assessments, 5-year renewals - Adopted at the CHMP meeting of 13-16 February 2012

Opinions on safety variations: Adopted at the CHMP meeting of 13-16 February 2012

Start of community reviews adopted during the CHMP meeting of 13-16 February 2012

Medicines granted a Community marketing authorisation under the centralised procedure from 01 January to 31 January 2012

Overview of invented names reviewed in January 2012 by the Name Review Group (NRG) adopted at the CHMP meeting of 13-16 February 2012

Scientific advice and protocol assistance adopted during the CHMP meeting 13-16 February 2012

Guidelines and concept papers: Adopted during the CHMP meeting 13-16 February 2012

Organisational matters - CHMP meeting 13-16 Febury 2012