International non-proprietary name (INN)

florbetapir (18F)

Marketing-authorisation applicant

Eli Lilly Nederland BV

Therapeutic indication

Radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β -amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment

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Summary of opinion for Amyvid

Press release: European Medicines Agency recommends approval of first radiopharmaceutical for PET imaging of β -amyloid neuritic plaque density

International non-proprietary name (INN)

mirabegron

Marketing-authorisation applicant

Astellas Pharma Europe BV

Therapeutic indication

Treatment of overactive bladder syndrome

More information

Summary of opinion for Betmiga

International non-proprietary name (INN)

pegloticase

Marketing-authorisation applicant

Savient Pharma Ireland Ltd

Therapeutic indication

Treatment of chronic gout

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Summary of opinion for Krystexxa

International non-proprietary name (INN)

insulin degludec

Marketing-authorisation applicant

Novo Nordisk A/S

Therapeutic indication

Treatment of diabetes mellitus

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Summary of opinion for Tresiba

Press release: European Medicines Agency recommends approval of first higher-strength insulin for treatment of patients with diabetes mellitus in the EU

International non-proprietary name (INN)

insulin degludec / insulin aspart

Marketing-authorisation applicant

Novo Nordisk A/S

Therapeutic indication

Treatment of diabetes mellitus

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Summary of opinion for Ryzodeg

International non-proprietary name (INN)

memantine hydrochloride / donepezil hydrochloride

Marketing-authorisation applicant

H. Lundbeck A/S

Therapeutic indication

Treatment of Alzheimer’s disease

More information

Questions and answers on Acrescent

International non-proprietary name (INN)

memantine hydrochloride / donepezil hydrochloride

Marketing-authorisation applicant

Merz Pharmaceuticals GmbH

Therapeutic indication

Treatment of Alzheimer’s disease

More information

Questions and answers on Balaxur

International non-proprietary name (INN)

phentermine / topiramate

Marketing-authorisation applicant

Vivus BV

Therapeutic indication

Treatment of obesity

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Questions and answers on Qsiva

International non-proprietary name (INN)

adalimumab

Marketing-authorisation holder

Abbott Laboratories Ltd

New therapeutic indication

Paediatric Crohn’s Disease

Humira is indicated for the treatment of severe active Crohn’s disease in paediatric patients (6 to 17 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.
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

International non-proprietary name (INN)

raltegravir

Marketing-authorisation holder

Merck Sharp & Dohme Ltd

Therapeutic indication
(changes in bold)

Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 2 years.

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Summary of opinion for Isentress

International non-proprietary name (INN)

thyrotropin alfa

Marketing-authorisation holder

Genzyme Europe BV

Therapeutic indication
(changes in bold)

Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST).
Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels.
Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4).

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Summary of opinion for Thyrogen

International non-proprietary name (INN)

rivaroxaban

Marketing-authorisation holder

Bayer Pharma AG

Therapeutic indication
(changes in bold)

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)

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Summary of opinion for Xarelto

International non-proprietary name (INN)

imatinib

Marketing-authorisation applicant

Teva Pharma BV

Therapeutic indication

Treatment of leukaemia

More information

Summary of opinion for Imatinib Teva

• Furosemide Vitabalans

furosemide

Vitabalans Oy

• Levothyroxine Alapis

levothyroxine

Alapis SA

• Loraxin

loratadine

Vitabalans Oy

• Tolperisone-containing medicines

• Press release: European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs
• Questions and answers on the review of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk

• Press release: European Medicines Agency reviews hypothesis on Pandemrix and development of narcolepsy

• 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 during the October 2012 CHMP meeting

• Overview of invented names reviewed in October 2012 by the Name Review Group (NRG)

• Organisational matters