Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012

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14/12/2012

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012

This page provides an overview of the opinions adopted at the December 2012 meeting of the CHMP and other important outcomes. 

In the table below, readers can view the main opinions adopted at the meeting, as well as information on referral procedures.

To review the individual press releases, question-and-answer documents and other documents, please click on the links under ‘more information’.

The Agency publishes a new page following the CHMP meeting each month.


Positive recommendations on new medicines

Name of medicineAdasuve
International non-proprietary name (INN)loxapine
Marketing-authorisation applicantAlexza UK Ltd
Therapeutic indicationRapid control of agitation
More informationSummary of opinion for Adasuve


Name of medicinePerjeta
INNpertuzumab
Marketing-authorisation applicantRoche Registration Ltd
Therapeutic indicationTreatment of breast cancer
More informationSummary of opinion for Perjeta


Name of medicineSelincro
INNnalmefene
Marketing-authorisation applicantH.Lundbeck A/S
Therapeutic indicationReduction of alcohol consumption in adult patients with alcohol dependence who have high drinking risk level, without physical withdrawal symptoms and who do not require immediate detoxification
More information

Summary of opinion for Selincro

Press release: European Medicines Agency recommends approval of medicine for reduction of alcohol consumption



Negative recommendations on new medicines

Name of medicineFanaptum
INNiloperidone
Marketing-authorisation applicantVanda Pharmaceuticals Ltd
Therapeutic indicationTreatment of schizophrenia
More informationQuestions and answers on the refusal of the marketing authorisation for Fanaptum

 

Name of medicineKynamro
INNmipomersen
Marketing-authorisation applicantGenzyme Europe B.V.
Therapeutic indicationTreatment of familial hypercholesterolaemia
More informationQuestions and answers on the refusal of the marketing authorisation for Kynamro



Positive recommendations on new therapeutic indications

Name of medicineAbilify
INNaripiprazole
Marketing-authorisation holderOtsuka Pharmaceutical Europe Ltd
Therapeutic indication (changes in bold)Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Abilify is indicated for the treatment of moderate to severe manic episodes in bipolar I disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.
Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar I disorder in adolescents aged 13 years and older.
More informationSummary of opinion for Abilify


Name of medicineIlaris
INNcanakinumab
Marketing-authorisation holderNovartis Europharm Ltd
Therapeutic indication (changes in bold)Treatment of cryopyrin-associated periodic syndromes (CAPS) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:
- Muckle-Wells syndrome (MWS);
- neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA);
- severe forms of familial cold auto-inflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.
More informationSummary of opinion for Ilaris


Name of medicineIxiaro
Common nameJapanese encephalitis vaccine (inactivated, adsorbed)
Marketing-authorisation holderIntercell AG
Therapeutic indication (changes in bold)

Ixiaro is indicated for active immunization against Japanese encephalitis in adults, adolescents, children and infants aged two months and older.

Ixiaro should be considered for use in individuals at risk of exposure through travel or in the course of their occupation. 

More informationSummary of opinion for Ixiaro



Recommendation for new contraindication

Name of medicinePradaxa
INNdabigatran etexilate
Marketing-authorisation holderBoehringer Ingelheim International GmbH
New contraindicationProsthetic heart valves requiring anticoagulant treatment
More informationSummary of opinion for Pradaxa

 

Public-health recommendation on non-centrally authorised medicines

Name of medicineTisseel, Tissucol, Artiss, Beriplast B
INNfibrinogen-containing solutions for sealant
More information

Questions and answers on the review of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names) given by spray application


Press release: European Medicines Agency recommends new advice on safer use of fibrin sealant spray applications



Public-health recommendation on centrally and non-centrally authorised medicines

Name of medicineM-M-RVAXPRO, ProQuad, Zostavax, Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R. Vax, Rouvax, Trivivac, Varilrix, Varivax, and associated names
INNmonovalent and multivalent rubella, measles, mumps and / or varicella vaccines
More informationQuestions and answers on the review of monovalent and multivalent measles, mumps, rubella and / or varicella vaccines



Re-examination of public-health recommendation

Name of medicineFenofibrato Pensa, Fenofibrato Ranbaxy
INNfenofibrate
More informationQuestions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility

 

Withdrawals of applications

Name of medicineCombimarv
INNinsulin human
More informationQuestions and answers on the withdrawal of the marketing authorisation application for Combimarv

 

Name of medicineIsomarv medium
INNinsulin human
More informationQuestions and answers on the withdrawal of the marketing authorisation application for Isomarv medium


Name of medicineSolumarv
INNinsulin human
More informationQuestions and answers on the withdrawal of the marketing authorisation application for Solumarv


Name of medicineJenzyl
INNridaforolimus
More informationQuestions and answers on on the withdrawal of the marketing authorisation application for Jenzyl



Other updates

Questions and answers on the use of phosphates in eye drops
Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Start of Community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Overview of invented names reviewed in December 2012 by the Name Review Group (NRG)
Organisational matters

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Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.

Contact point:

Martin Harvey Allchurch
Tel. +44 (0)20 7418 8699
E-mail: press@ema.europa.eu