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 medicine||Adasuve|
|International non-proprietary name (INN)||loxapine|
|Marketing-authorisation applicant||Alexza UK Ltd|
|Therapeutic indication||Rapid control of agitation|
|More information||Summary of opinion for Adasuve|
|Name of medicine||Perjeta|
|Marketing-authorisation applicant||Roche Registration Ltd|
|Therapeutic indication||Treatment of breast cancer|
|More information||Summary of opinion for Perjeta|
|Name of medicine||Selincro|
|Marketing-authorisation applicant||H.Lundbeck A/S|
|Therapeutic indication||Reduction 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|
Negative recommendations on new medicines
|Name of medicine||Fanaptum|
|Marketing-authorisation applicant||Vanda Pharmaceuticals Ltd|
|Therapeutic indication||Treatment of schizophrenia|
|More information||Questions and answers on the refusal of the marketing authorisation for Fanaptum|
|Name of medicine||Kynamro|
|Marketing-authorisation applicant||Genzyme Europe B.V.|
|Therapeutic indication||Treatment of familial hypercholesterolaemia|
|More information||Questions and answers on the refusal of the marketing authorisation for Kynamro|
Positive recommendations on new therapeutic indications
|Name of medicine||Abilify|
|Marketing-authorisation holder||Otsuka 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 information||Summary of opinion for Abilify|
|Name of medicine||Ilaris|
|Marketing-authorisation holder||Novartis 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 information||Summary of opinion for Ilaris|
|Name of medicine||Ixiaro|
|Common name||Japanese encephalitis vaccine (inactivated, adsorbed)|
|Marketing-authorisation holder||Intercell 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 information||Summary of opinion for Ixiaro|
Recommendation for new contraindication
|Name of medicine||Pradaxa|
|Marketing-authorisation holder||Boehringer Ingelheim International GmbH|
|New contraindication||Prosthetic heart valves requiring anticoagulant treatment|
|More information||Summary of opinion for Pradaxa|
Public-health recommendation on non-centrally authorised medicines
|Name of medicine||Tisseel, Tissucol, Artiss, Beriplast B|
|INN||fibrinogen-containing solutions for sealant|
Public-health recommendation on centrally and non-centrally authorised medicines
|Name of medicine||M-M-RVAXPRO, ProQuad, Zostavax, Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R. Vax, Rouvax, Trivivac, Varilrix, Varivax, and associated names|
|INN||monovalent and multivalent rubella, measles, mumps and / or varicella vaccines|
|More information||Questions and answers on the review of monovalent and multivalent measles, mumps, rubella and / or varicella vaccines|
Re-examination of public-health recommendation
|Name of medicine||Fenofibrato Pensa, Fenofibrato Ranbaxy|
|More information||Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility|
Withdrawals of applications
|Name of medicine||Combimarv|
|More information||Questions and answers on the withdrawal of the marketing authorisation application for Combimarv|
|Name of medicine||Isomarv medium|
|More information||Questions and answers on the withdrawal of the marketing authorisation application for Isomarv medium|
|Name of medicine||Solumarv|
|More information||Questions and answers on the withdrawal of the marketing authorisation application for Solumarv|
|Name of medicine||Jenzyl|
|More information||Questions and answers on on the withdrawal of the marketing authorisation application for Jenzyl|
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- Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines: Article-31 referral
- Medicines studied at Cetero Research facility: Article-31 referral
- Fibrinogen-containing solutions for sealant authorised for administration by spray application: Article-31 referral
- European Medicines Agency recommends new advice on safer use of fibrin sealant spray applications (14/12/2012)
- European Medicines Agency recommends approval of medicine for reduction of alcohol consumption (14/12/2012)
- Committee for Medicinal Products for Human Use (CHMP): 10-13 December 2012
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.
Martin Harvey Allchurch
Tel. +44 (0)20 7418 8699