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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 2013
London, UK (January 18, 2013) – This page provides an overview of the opinions adopted at the January 2013 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. The new public-health communication document on Agency’s recommendation to suspend Tredaptive, Pelzont and Trevaclyn combines the press release and question-and-answer document previously published following CHMP meetings. The Agency publishes a new page following the CHMP meeting each month.
Positive recommendations on new medicines
Name of medicine |
Bosulif |
International non-proprietary name (INN) |
bosutinib |
Marketing-authorisation applicant |
Pfizer Ltd |
Therapeutic indication |
Treatment of chronic myelogenous leukaemia |
More information |
Name of medicine |
Jetrea |
INN |
ocriplasmin |
Marketing-authorisation applicant |
ThromboGenics NV |
Therapeutic indication |
Treatment of symptomatic vitreomacular adhesion |
More information |
Negative recommendation on new medicine
Name of medicine |
Raxone |
INN |
idebenone |
Marketing-authorisation applicant |
Santhera Pharmaceuticals (Deutschland) GmbH |
Therapeutic indication |
Treatment of Leber’s hereditary optic neuropathy |
More information |
Questions and answers on the refusal of the marketing authorisation for Raxone |
Positive recommendations on new generic medicines
Name of medicine |
Actelsar HCT |
INN |
telmisartan / hydrochlorothiazide |
Marketing-authorisation applicant |
Actavis Group PTC |
Therapeutic indication |
Treatment of essential hypertension |
More information |
Name of medicine |
Maruxa |
INN |
memantine |
Marketing-authorisation applicant |
Krka dd Novo mesto |
Therapeutic indication |
Treatment of Alzheimer’s disease |
More information |
Name of medicine |
Tolucombi |
INN |
telmisartan / hydrochlorothiazide |
Marketing-authorisation applicant |
Krka dd Novo mesto |
Therapeutic indication |
Treatment of essential hypertension |
More information |
Positive recommendations on extensions of therapeutic indications
Name of medicine |
Humira |
INN |
adalimumab |
Marketing-authorisation holder |
Abbott Laboratories Ltd |
Change to a therapeutic indication |
Polyarticular juvenile idiopathic arthritis Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 2 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Humira has not been studied in children aged less than 2 years. |
More information |
Name of medicine |
Ilaris |
INN |
canakinumab |
Marketing-authorisation holder |
Novartis Europharm Ltd |
Therapeutic indication |
Cryopyrin-associated periodic syndromes Gouty arthritis: |
More information |
Name of medicine |
Komboglyze |
INN |
saxagliptin / metformin hydrychloride |
Marketing-authorisation holder |
Bristol-Myers Squibb |
Therapeutic indication |
Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets. Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type 2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control. Komboglyze is also indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type 2 diabetes mellitus when the maximally tolerated dose of both metformin and the sulphonylurea does not provide adequate glycaemic control. |
More information |
Name of medicine |
Onglyza |
INN |
saxagliptin |
Marketing-authorisation holder |
Astra Zeneca EEIG |
Therapeutic indication |
Onglyza is indicated in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control: as dual oral therapy in combination with as triple oral therapy in combination with |
More information |
Name of medicine |
Pegasys |
INN |
peginterferon alfa-2a |
Marketing-authorisation holder |
Roche Registration Ltd |
New indication |
Paediatric patients 5 years of age and older: Pegasys in combination with ribavirin is indicated for the treatment of chronic hepatitis C in treatment-naïve children and adolescents 5 years of age and older, who are positive for serum HCV-RNA. When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4). |
More information |
Outcome of arbitration procedure
Name of medicine |
Kantos Master and associated names |
INN |
beclometasone dipropionate / formoterol fumarate |
Marketing-authorisation holder |
Chiesi Farmaceutici S.p.A |
More information |
Withdrawals of applications
Name of medicine |
Loulla |
INN |
mercaptopurine |
More information |
Questions and answers on the withdrawal of the marketing authorisation application for Loulla |
Name of medicine |
Memantine FGK |
INN |
memantine |
More information |
Questions and answers on the withdrawal of the marketing authorisation application for Memantine FGK |
Public-health communication
European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn |
Other updates
Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures |
Opinions on safety variations |
Start of community reviews |
Guidelines and concept papers adopted |
Overview of invented names reviewed in January 2012 by the Name Review Group (NRG) |
Organisational matters |
European Medicines Agency (EMA), 18.01.2013 (tB).