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

 

London, UK (December 14, 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

INN

pertuzumab

Marketing-authorisation applicant

Roche Registration Ltd

Therapeutic indication

Treatment of breast cancer

More information

Summary of opinion for Perjeta

 

Name of medicine

Selincro

INN

nalmefene

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

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 medicine

Fanaptum

INN

iloperidone

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

INN

mipomersen

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

INN

aripiprazole

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

INN

canakinumab

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 autoinflammatory 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

INN

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 2 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

INN

dabigatran etexilate

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

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 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 varicella vaccine

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

INN

fenofibrate

More information

Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility – re-examination

 

 

Withdrawals of applications

 

Name of medicine

Combimarv

INN

insulin human

More information

Questions and answers on the withdrawal of the marketing authorisation application for Combimarv

 

Name of medicine

Isomarv medium

INN

insulin human

More information

Questions and answers on the withdrawal of the marketing authorisation application for Isomarv medium

 

Name of medicine

Solumarv

INN

insulin human

More information

Questions and answers on the withdrawal of the marketing authorisation application for Solumarv

 

Name of medicine

Jenzyl

INN

ridaforolimus

More information

Questions and answers on on the withdrawal of the marketing authorisation application for Jenzyl

 

 

Other updates

 

  • Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
  • Opinions on safety variations
  • Guidelines and concept papers adopted
  • Organisational matters

 


 

European Medicines Agency (EMA), 14.12.2012 (hB).

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