International non-proprietary name (INN)

meningococcal group B vaccine (rDNA, component, adsorbed)

Marketing-authorisation applicant

Novartis Vaccines and Diagnostics S.r.l.

Therapeutic indication

Active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.

More information

Summary of opinion for Bexsero

Press release: European Medicines Agency recommends approval of first vaccine for meningitis B

INN

lixisenatide

Marketing-authorisation applicant

Sanofi-Aventis

Therapeutic indication

Treatment of type 2 diabetes mellitus

More information

Summary of opinion for Lyxumia (document not yet available)

INN

aflibercept

Marketing-authorisation applicant

Sanofi-Aventis

Therapeutic indication

Treatment of metastatic colorectal cancer

More information

Summary of opinion for Zaltrap

INN

romidepsin

Marketing-authorisation holder

Celgene Europe Ltd

Therapeutic indication

Treatment of peripheral T-cell lymphoma

More information

Questions and answers on Istodax

INN

etravirine

Marketing-authorisation holder

Janssen-Cilag International N.V.

Therapeutic indication
(changes in bold)

Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and in antiretroviral treatment-experienced paediatric patients from 6 years of age (see sections 4.4, 4.5 and 5.1).
The indication in adults is based on week 48 analyses from 2 Phase III trials in highly pre-treated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, Phase II trial in antiretroviral treatment-experienced paediatric patients (see section 5.1).

More information

Summary of opinion for Intelence

INN

deferasirox

Marketing-authorisation holder

Novartis Europharm Ltd

New therapeutic indication

Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with nontransfusion- dependent thalassaemia syndromes aged 10 years and older.

More information

Summary of opinion for Exjade

INN

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Marketing-authorisation holder

Pfizer Ltd

Therapeutic indication
(changes in bold)

Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 17 years of age.
Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.
See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.
The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.

More information

Summary of opinion for Prevenar 13

INN

abiraterone

Marketing-authorisation holder

Janssen-Cilag International N.V.

Therapeutic indication
(changes in bold)

Zytiga is indicated with prednisone or prednisolone for:
– the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
– the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

More information

Summary of opinion for Zytiga

INN

human fibrinogen / human thrombin

Marketing-authorisation holder

Nycomed Austria GmbH

Contraindications
(changes in bold)

TachoSil must not be applied intravascularly.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

More information

Summary of opinion for Tachosil

Press release: European Medicines Agency recommends new advice to surgeons on safer use of fibrin sealants Evicel and Quixil

Questions and answers on review of the fibrin sealants Evicel and Quixil given by spray application

Recommended product information will be available later.

Calcitonin-containing medicines

Press release: European Medicines Agency completes review of protamine-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 November 2012 by the Name Review Group (NRG)

Organisational matters