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

PDF iconPixuvri

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

PDF iconPyramax

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

pyronaridine / artesunateShin Poong Pharmaceutical Co., Ltd
PDF iconSancuso granisetronProStrakan Ltd

Positive opinions on generics

Name of medicineINNMarketing authorisation applicant
PDF iconCapecitabine Accord capecitabineAccord Healthcare Ltd
PDF iconCapecitabine Krka capecitabineKrka, d.d., Novo mesto
PDF iconCapecitabine Teva capecitabineTeva Pharma B.V.
PDF iconSabervel irbesartanPharmathen S.A.
Zoledronic Acid Actaviszoledronic acidActavis Group PTC ehf

Positive opinion on informed consent application

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

Positive opinions on extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
PDF iconByetta exenatideEli Lilly Nederland B.V.
PDF iconHumira adalimumabAbbott Laboratories Ltd
PDF iconPegIntron peginterferon alfa-2bSchering-Plough Europa
PDF iconRebetol 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 iconHalaven eribulinEisai Europe Ltd

Other updates

PDF iconOpinions on consultation procedures on ancillary medicinal substances in medicinal devices
PDF iconOpinions on annual re-assessments and renewals
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconMedicines granted a Community marketing authorisation under the centralised procedure since the January CHMP meeting
PDF iconOverview of invented names reviewed in January 2012 by the Name Review Group (NRG)
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted during the February 2012 CHMP meeting
PDF iconOrganisational matters

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