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.
 

Positive recommendations on new medicines

 

Name of medicine

Aubagio

International non-proprietary name (INN)

teriflunomide

Marketing-authorisation applicant

Sanofi-aventis

Therapeutic indication

Treatment of multiple sclerosis

More information

 

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

 

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

  

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

 

Name of medicine

Tecfidera

Common name

dimethyl fumarate

Marketing-authorisation applicant

Biogen Idec Ltd

Therapeutic indication

Treatment of multiple sclerosis

More information

 

Negative recommendations on new medicines

 

Name of medicine

Defitelio

INN

defibrotide

Marketing-authorisation applicant

Gentium SpA

Therapeutic indication

Prevention and treatment of hepatic veno-occlusive disease

More information

 

Name of medicine

Labazenit

INN

budesonide / salmeterol

Marketing-authorisation applicant

Laboratoires SMB S.A.

Therapeutic indication

Treatment of asthma

More information

 

Positive recommendation on informed consent application

 

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

 

Positive recommendations on new generic medicines

 

Name of medicine

Memantine ratiopharm

INN

memantine hydrochloride

Marketing-authorisation applicant

ratiopharm GmbH

Therapeutic indication

Treatment of Alzheimer’s disease

More information

 

Name of medicine

Voriconazole Accord

INN

voriconazole

Marketing-authorisation applicant

Accord Healthcare Ltd.

Therapeutic indication

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

More information

 

Re-examination of recommendation for new medicine

 

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

  

Positive recommendations on extensions of therapeutic indications 

 

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

 

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 uremic syndrome (aHUS) (see section 5.1).

More information

 

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

 

Name of medicine

Xarelto

INN

rivaroxaban

Marketing-authorisation holder

Bayer Pharma AG

New indication

Xarelto 2.5mg

– 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

 



Withdrawals of application

 

Name of medicine

Fanaptum

INN

iloperidone

More information

 

Name of medicine

OraNera

INN

autologous oral mucosal epithelial cells

More information





Public-health recommendation

 





Other updates

 

  • Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
  • Opinions on safety variations
  • 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

 

Posted on the EMA website on 22 March 2013