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
Negative recommendations on new medicines
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.
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.
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.
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|
Summary of opinion for Pradaxa
Public-health recommendation on non-centrally authorised medicines
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|
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|
Withdrawals of applications