International non-proprietary name (INN)

teriflunomide

Marketing-authorisation applicant

Sanofi-aventis

Therapeutic indication

Treatment of multiple sclerosis

More information

Summary of opinion for Aubagio

Common name

human normal immunoglobulin

Marketing-authorisation applicant

Baxter Innovations GmbH

Therapeutic indication

Replacement therapy for primary immunodeficiency syndromes and secondary hypogammaglobulinemia

More information

Summary of opinion for HyQvia

INN

ponatinib

Marketing-authorisation applicant

Ariad Pharma Ltd

Therapeutic indication

Treatment of chronic myeloid leukaemia or Philadelphia-chromosome-positive acute lymphoblastic leukaemia

More information

Summary of opinion for Iclusig

INN

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

Marketing-authorisation applicant

Gilead Sciences International Ltd

Therapeutic indication

Treatment of human immunodeficiency virus-1 (HIV-1)

More information

Summary of opinion for Stribild

Common name

dimethyl fumarate

Marketing-authorisation applicant

Biogen Idec Ltd

Therapeutic indication

Treatment of multiple sclerosis

More information

Summary of opinion for Tecfidera

INN

defibrotide

Marketing-authorisation applicant

Gentium SpA

Therapeutic indication

Prevention and treatment of hepatic veno-occlusive disease

More information

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

INN

budesonide / salmeterol

Marketing-authorisation applicant

Laboratoires SMB S.A.

Therapeutic indication

Treatment of asthma

More information

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

INN

bosentan monohydrate

Marketing-authorisation applicant

Marklas Nederland BV

Therapeutic indication

Treatment of pulmonary arterial hypertension and digital ulcer disease

More information

Summary of opinion for Stayveer

INN

memantine hydrochloride

Marketing-authorisation applicant

ratiopharm GmbH

Therapeutic indication

Treatment of Alzheimer’s disease

More information

Summary of opinion for Memantine ratiopharm

INN

voriconazole

Marketing-authorisation applicant

Accord Healthcare Ltd.

Therapeutic indication

Treatment of invasive aspergillosis, candidaemia in non-neutropenic patients, fluconazole-resistant serious invasive Candida infections, fungal infections caused by Scedosporium spp. and Fusarium spp.

More information

Summary of opinion for Voriconazole Accord

INN

mipomersen

Marketing-authorisation applicant

Genzyme Europe BV

Therapeutic indication

Adjunct to maximally tolerated lipid-lowering medicines and diet to reduce low density lipoprotein-cholesterol in adults patients with homozygous familial hypercholesterolaemia

More information

Questions and answers on the refusal of the marketing authorisation for Kynamro – Outcome of re-examination

INN

rituximab

Marketing-authorisation holder

Roche Registration Ltd

New therapeutic indication

Granulomatosis with polyangiitis and microscopic polyangiitis

MabThera, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).

More information

Summary of opinion for Mabthera

INN

eculizumab

Marketing-authorisation holder

Alexion Europe SAS

Change to a therapeutic indication
(changes in bold)

Soliris is indicated in adults and children for the treatment of patients with
– paroxysmal nocturnal haemoglobinuria (PNH).
Evidence of clinical benefit of Soliris in the treatment of patients with PNH is limited to patients with history of transfusions;
– atypical haemolytic uraemic syndrome (aHUS) (see section 5.1).

More information

Summary of opinion for Soliris

INN

tenofovir disoproxil fumarate

Marketing-authorisation holder

Gilead Sciences International Ltd

Change to a therapeutic indication
(changes in bold)

Hepatitis-B infection

Viread 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with:

Viread 33 mg/g granules are indicated for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate with:

– compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and / or fibrosis (see section 5.1);
– evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1);
– decompensated liver disease (see sections 4.4, 4.8 and 5.1).

Viread 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:

Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age for whom a solid dosage form is not appropriate with:

– compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and / or fibrosis (see sections 4.4, 4.8 and 5.1).

More information

Summary of opinion for Viread

INN

rivaroxaban

Marketing-authorisation holder

Bayer Pharma AG

New indication

Xarelto 2.5 mg

– Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1).

More information

Summary of opinion for Xarelto

INN

iloperidone

More information

Fanaptum: Withdrawn application

INN

autologous oral mucosal epithelial cells

More information

OraNera: Withdrawn application

European Medicines Agency recommends restricting use of cilostazol-containing medicines

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 February 2013 by the Name Review Group (NRG)

Organisational matters

Opinions on consultation procedures on ancillary medicinal substances in medical devices