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

  • Email
  • Help

News

22/03/2013

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.


Positive recommendations on new medicines

Name of medicineAubagio
International non-proprietary name (INN)teriflunomide
Marketing-authorisation applicantSanofi-aventis
Therapeutic indicationTreatment of multiple sclerosis
More informationSummary of opinion for Aubagio

 

Name of medicineHyQvia
Common namehuman normal immunoglobulin
Marketing-authorisation applicantBaxter Innovations GmbH
Therapeutic indicationReplacement therapy for primary immunodeficiency syndromes and secondary hypogammaglobulinemia
More informationSummary of opinion for HyQvia


Name of medicineIclusig
INNponatinib
Marketing-authorisation applicantAriad Pharma Ltd
Therapeutic indicationTreatment of chronic myeloid leukaemia or Philadelphia-chromosome-positive acute lymphoblastic leukaemia
More informationSummary of opinion for Iclusig

  

Name of medicineStribild
INNelvitegravir / cobicistat / emtricitabine / tenofovir disoproxil
Marketing-authorisation applicantGilead Sciences International Ltd
Therapeutic indicationTreatment of human immunodeficiency virus-1 (HIV-1)
More informationSummary of opinion for Stribild

 

Name of medicineTecfidera
Common namedimethyl fumarate
Marketing-authorisation applicantBiogen Idec Ltd
Therapeutic indicationTreatment of multiple sclerosis
More informationSummary of opinion for Tecfidera

 

Negative recommendations on new medicines

Name of medicineDefitelio
INNdefibrotide
Marketing-authorisation applicantGentium SpA
Therapeutic indicationPrevention and treatment of hepatic veno-occlusive disease
More informationQuestions and answers on the refusal of the marketing authorisation for Defitelio

 

Name of medicineLabazenit
INNbudesonide / salmeterol
Marketing-authorisation applicantLaboratoires SMB S.A.
Therapeutic indicationTreatment of asthma
More informationQuestions and answers on the refusal of the marketing authorisation for Labazenit

 

Positive recommendation on informed-consent application

Name of medicineStayveer
INNbosentan monohydrate
Marketing-authorisation applicantMarklas Nederland BV
Therapeutic indicationTreatment of pulmonary arterial hypertension and digital ulcer disease
More informationSummary of opinion for Stayveer

 

Positive recommendations on new generic medicines

Name of medicineMemantine ratiopharm
INNmemantine hydrochloride
Marketing-authorisation applicantratiopharm GmbH
Therapeutic indicationTreatment of Alzheimer's disease
More informationSummary of opinion for Memantine ratiopharm

 

Name of medicineVoriconazole Accord
INNvoriconazole
Marketing-authorisation applicantAccord Healthcare Ltd.
Therapeutic indicationTreatment of invasive aspergillosis, candidaemia in non-neutropenic patients, fluconazole-resistant serious invasive Candida infections, fungal infections caused by Scedosporium spp. and Fusarium spp.
More informationSummary of opinion for Voriconazole Accord

 

Re-examination of recommendation for new medicine

Name of medicineKynamro
INNmipomersen
Marketing-authorisation applicantGenzyme Europe BV
Therapeutic indicationAdjunct to maximally tolerated lipid-lowering medicines and diet to reduce low density lipoprotein-cholesterol in adults patients with homozygous familial hypercholesterolaemia
More informationQuestions and answers on the refusal of the marketing authorisation for Kynamro - Outcome of re-examination

  

Positive recommendations on extensions of therapeutic indications 

Name of medicineMabThera
INNrituximab
Marketing-authorisation holderRoche 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 informationSummary of opinion for Mabthera

 

Name of medicineSoliris
INNeculizumab
Marketing-authorisation holderAlexion 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 informationSummary of opinion for Soliris

 

Name of medicineViread
INNtenofovir disoproxil fumarate
Marketing-authorisation holderGilead 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 informationSummary of opinion for Viread


Name of medicineXarelto
INNrivaroxaban
Marketing-authorisation holderBayer 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 informationSummary of opinion for Xarelto



Withdrawals of application

Name of medicineFanaptum
INNiloperidone
More informationFanaptum: Withdrawn application

 

Name of medicineOraNera
INNautologous oral mucosal epithelial cells
More informationOraNera: Withdrawn application



Public-health recommendation

European Medicines Agency recommends restricting use of cilostazol-containing medicines



Other updates

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

Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.

Contact point:

Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu