Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013

This page provides an overview of the opinions adopted at the March 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 Agency publishes a new page following the CHMP meeting each month.

Name of medicine	Aubagio
International non-proprietary name (INN)	teriflunomide
Marketing-authorisation applicant	Sanofi-aventis
Therapeutic indication	Treatment of multiple sclerosis
More information	CHMP summary of positive opinion for Aubagio

Name of medicine	HyQvia
Common name	human normal immunoglobulin
Marketing-authorisation applicant	Baxter Innovations GmbH
Therapeutic indication	Replacement therapy for primary immunodeficiency syndromes and secondary hypogammaglobulinemia
More information	CHMP summary of positive opinion for HyQvia

Name of medicine	Iclusig
INN	ponatinib
Marketing-authorisation applicant	Ariad Pharma Ltd
Therapeutic indication	Treatment of chronic myeloid leukaemia or Philadelphia-chromosome-positive acute lymphoblastic leukaemia
More information	CHMP summary of positive opinion for Iclusig

Name of medicine	Stribild
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	CHMP summary of positive opinion for Stribild

Name of medicine	Tecfidera
Common name	dimethyl fumarate
Marketing-authorisation applicant	Biogen Idec Ltd
Therapeutic indication	Treatment of multiple sclerosis
More information	CHMP summary of positive opinion for Tecfidera

Name of medicine	Defitelio
INN	defibrotide
Marketing-authorisation applicant	Gentium SpA
Therapeutic indication	Prevention and treatment of hepatic veno-occlusive disease
More information	Questions and answers on refusal of the marketing authorisation for Defitelio

Name of medicine	Labazenit
INN	budesonide / salmeterol
Marketing-authorisation applicant	Laboratoires SMB S.A.
Therapeutic indication	Treatment of asthma
More information	Questions and answers on refusal of the marketing authorisation for Labazenit

Name of medicine	Stayveer
INN	bosentan monohydrate
Marketing-authorisation applicant	Marklas Nederland BV
Therapeutic indication	Treatment of pulmonary arterial hypertension and digital ulcer disease
More information	CHMP summary of positive opinion for Stayveer

Name of medicine	Memantine ratiopharm
INN	memantine hydrochloride
Marketing-authorisation applicant	ratiopharm GmbH
Therapeutic indication	Treatment of Alzheimer's disease
More information	CHMP summary of positive opinion for Memantine ratiopharm

Name of medicine	Voriconazole Accord
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	CHMP summary of positive opinion for Voriconazole Accord

Name of medicine	Kynamro
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

Name of medicine	MabThera
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	CHMP post-authorisation summary of positive opinion for MabThera

Name of medicine	Soliris
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	CHMP post-authorisation summary of positive opinion for Soliris

Name of medicine	Viread
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	CHMP post-authorisation summary of positive opinion for Viread

Name of medicine	Xarelto
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	CHMP post-authorisation summary of positive opinion for Xarelto