Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013
News
Human
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 | 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 |
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 | 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 |
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 | CHMP summary of positive opinion for Stayveer |
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 | 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 |
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 | Questions and answers on the refusal of the marketing authorisation for Kynamro - Outcome of re-examination |
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 | 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); 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 |
Withdrawals of application
| Name of medicine | Fanaptum |
|---|---|
| INN | iloperidone |
| More information | Fanaptum: Withdrawn application |
| Name of medicine | OraNera |
|---|---|
| INN | autologous oral mucosal epithelial cells |
| More information | OraNera: Withdrawn application |
Public-health recommendation
Other updates
| Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 18-21 March 2013 |
| Opinions on safety variations adopted at the CHMP meeting of 18-21 March 2013 |
| Start of community reviews - CHMP meeting of 18-21 March 2013 |
| Scientific advice and protocol assistance adopted during the CHMP meeting of 18-21 March 2013 |
| Guidelines and concept papers adopted during the CHMP meeting 18-21 March 2013 |
| Overview of invented names reviewed in February 2013 by the Name Review Group (NRG) |
| Organisational matters - CHMP meeting of 18-21 March 2013 |
| Opinions on consultation procedures on ancillary medicinal substances in medical devices |