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

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

London, UK (February 17, 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.

Positive opinions on new medicines

Name of medicine	INN	Marketing authorisation applicant
Nimenrix	Meningococcal Group A, C, W-135 and Y conjugate vaccine	GlaxoSmithKline 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 Dimaleate	CTI Life Sciences Ltd
Pyramax Press release: European Medicines Agency recommends new anti-malaria treatment for use outside the European Union	Pyronaridine / Artesunate	Shin Poong Pharmaceutical Co., Ltd
Sancuso	Granisetron	ProStrakan Ltd

Positive opinions on generics

Name of medicine	INN	Marketing authorisation applicant
Capecitabine Accord	Capecitabine	Accord Healthcare Ltd
Capecitabine Krka	Capecitabine	Krka, d.d., Novo mesto
Capecitabine Teva	Capecitabine	Teva Pharma B.V.
Sabervel	Irbesartan	Pharmathen S.A.
Zoledronic acid Actavis	Zoledronic Acid	Actavis Group PTC ehf

Positive opinion on informed consent application

Name of medicine	INN	Marketing authorisation holder
Riluzole Zentiva	Riluzole	Pharma S.A.

Positive opinions on extensions of therapeutic indications

Name of medicine	INN	Marketing authorisation holder
BYETTA	Exenatide	Eli Lilly Nederland B.V.
Humira	Adalimumab	Abbott Laboratories Ltd
PegIntron	Peginterferon alfa-2b	Schering-Plough Europa
Rebetol	Ribavirin	Schering-Plough Europa
ViraferonPeg	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

Press release: European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines

aliskiren

Novartis Europharm Ltd

Final opinions on reviews for centrally and non-centrally authorised medicines relating to manufacturing issues

Name of medicine

Medicines manufactured at Ben Venu Laboratories
Angiox, Busilvex, Cayston, Ecalta, Luminity, Mepact, Soliris, Torisel, Velcade, Vibativ, Vidaza, Vistide

Press release: European Medicines Agency gives final recommendations for 12 centrally authorised medicines manufactured at Ben Venue Laboratories

Final opinions on safety reviews for centrally and non-centrally authorised medicines

Name of medicine	INN
Anti-tuberculosis medicines Press release: European Medicines Agency concludes review of dose recommendations for anti-tuberculosis medicines used in children	isoniazide, rifampicine, pyrazinamide, ethambutol, rifabutin
Antifibrinolytics containing medicines Press release: European Medicines Agency recommends lifting suspension of aprotinin	aprotinin, aminocaproic acid or tranexamic acid
Vivaglobin	human normal immunoglobulin solution for injection (subcutaneous use)
Orlistat-containing medicines Xenical, Alli, Generics Press release: European Medicines Agency confirms positive benefit-risk balance of orlistat-containing medicines	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
Halaven	Eribulin	Eisai 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

European Medicines Agency, 17.02.2012 (tB).