International non-proprietary name (INN)

bosutinib

Marketing-authorisation applicant

Pfizer Ltd

Therapeutic indication

Treatment of chronic myelogenous leukaemia

More information

Summary of opinion for Bosulif

INN

ocriplasmin

Marketing-authorisation applicant

ThromboGenics NV

Therapeutic indication

Treatment of symptomatic vitreomacular adhesion

More information

Summary of opinion for Jetrea

Press release: European Medicines Agency recommends approval of medicine for treatment of vitreomacular traction

INN

idebenone

Marketing-authorisation applicant

Santhera Pharmaceuticals (Deutschland) GmbH

Therapeutic indication

Treatment of Leber’s hereditary optic neuropathy

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Questions and answers on the refusal of the marketing authorisation for Raxone

INN

telmisartan / hydrochlorothiazide

Marketing-authorisation applicant

Actavis Group PTC

Therapeutic indication

Treatment of essential hypertension

More information

Summary of opinion for Actelsar HCT

INN

memantine

Marketing-authorisation applicant

Krka dd Novo mesto

Therapeutic indication

Treatment of Alzheimer’s disease

More information

Summary of opinion for Maruxa

INN

telmisartan / hydrochlorothiazide

Marketing-authorisation applicant

Krka dd Novo mesto

Therapeutic indication

Treatment of essential hypertension

More information

Summary of opinion for Tolucombi

INN

adalimumab

Marketing-authorisation holder

Abbott Laboratories Ltd

Change to a therapeutic indication
(changes in bold)

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.

Detailed conditions for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

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Summary of opinion for Humira

INN

canakinumab

Marketing-authorisation holder

Novartis Europharm Ltd

Therapeutic indication
(changes in bold)

Cryopyrin-associated periodic syndromes

Ilaris is indicated for the 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.

Gouty arthritis:
Ilaris is indicated for the symptomatic treatment of adults patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (see section 5.1).

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Summary of opinion for Ilaris

INN

saxagliptin / metformin hydrychloride

Marketing-authorisation holder

Bristol-Myers Squibb

Therapeutic indication
(changes in bold)

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.

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Summary of opinion for Komboglyze

INN

saxagliptin

Marketing-authorisation holder

Astra Zeneca EEIG

Therapeutic indication
(changes in bold)

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
– metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control.
– a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control. in patients for whom use of metformin is considered inappropriate.
– a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.

as triple oral therapy in combination with
– metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control

as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

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Summary of opinion for Onglyza

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).

Detailed conditions for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

More information

Summary of opinion for Pegasys

INN

beclometasone dipropionate / formoterol fumarate

Marketing-authorisation holder

Chiesi Farmaceutici S.p.A

More information

Questions and answers on Kantos Master and associated names

INN

mercaptopurine

More information

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

INN

memantine

More information

Questions and answers on the withdrawal of the marketing authorisation application for Memantine FGK

European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn

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 January 2012 by the Name Review Group (NRG)

Organisational matters