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).

 

MEDICAL NEWS

Inadequate sequencing of SARS-CoV-2 variants impedes global response to COVID-19
New meta-analysis finds cannabis may be linked to development of…
New guidance on how to diagnosis and manage osteoporosis in…
Starting the day off with chocolate could have unexpected benefits
Better mental health supports for nurses needed, study finds

SCHMERZ PAINCARE

Versorgung verbessern: Deutsche Gesellschaft für Schmerzmedizin fordert die Einführung des…
Pflegeexpertise im Fokus: Schmerzmanagement nach Operationen
Versorgung verbessern: Bundesweite Initiative der Deutschen Gesellschaft für Schmerzmedizin zu…
Jedes vierte Kind wünscht bessere Schmerzbehandlung
Lebensqualität von Patienten in der dauerhaften Schmerztherapie mit Opioiden verbessern

DIABETES

Bundestag berät über DMP Adipositas: DDG begrüßt dies als Teil…
Mit der Smartwatch Insulinbildung steuern
Verbände fordern bessere Ausbildung und Honorierung von Pflegekräften für Menschen…
Minimalinvasive Geräte warnen ungenügend vor Unterzuckerung
Typ-1-Diabetes und Hashimoto-Thyreoiditis treten häufig gemeinsam auf

ERNÄHRUNG

Wie eine Diät die Darmflora beeinflusst: Krankenhauskeim spielt wichtige Rolle…
DGEM plädiert für Screening und frühzeitige Aufbautherapie: Stationäre COVID-19-Patienten oft…
Führt eine vegane Ernährungsweise zu einer geringeren Knochengesundheit?
Regelmässiger Koffeinkonsum verändert Hirnstrukturen
Corona-Erkrankung: Fehl- und Mangelernährung sind unterschätze Risikofaktoren

ONKOLOGIE

Anti-Myelom-Therapie mit zusätzlich Daratumumab noch effektiver
Positive Ergebnisse beim fortgeschrittenen Prostatakarzinom: Phase-III-Studie zur Radioligandentherapie mit 177Lu-PSMA-617
Lymphom-News vom EHA2021 Virtual. Alle Berichte sind nun online verfügbar!
Deutsch-dänisches Interreg-Projekt: Grenzübergreifende Fortbildungskurse in der onkologischen Pflege
Sotorasib: Neues Medikament macht Lungenkrebs-Patienten Hoffnung

MULTIPLE SKLEROSE

NMOSD-Erkrankungen: Zulassung von Satralizumab zur Behandlung von Jugendlichen und Erwachsenen
Verzögerte Verfügbarkeit von Ofatumumab (Kesimpta®)
Neuer Biomarker bei Multipler Sklerose ermöglicht frühe Risikoeinschätzung und gezielte…
Multiple Sklerose beginnt oft lange vor der Diagnose
Goldstandard für Versorgung bei Multipler Sklerose

PARKINSON

Meilenstein in der Parkinson-Frühdiagnose
Parkinson-Erkrankte besonders stark von Covid-19 betroffen
Gangstörungen durch Kleinhirnschädigung beim atypischen Parkinson-Syndrom
Parkinson-Agenda 2030: Die kommenden 10 Jahre sind für die therapeutische…
Gemeinsam gegen Parkinson: bessere Therapie durch multidisziplinäre Versorgung