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EMA Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2012
London (November 16, 2012) – This page provides an overview of the opinions adopted at the November 2012 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. To review the individual press releases, question-and-answer documents and other documents, please click on the links under ‘more information’.
The Agency publishes a new page following the CHMP meeting each month.
Positive recommendations on new medicines
Name of medicine
|
Bexsero
|
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
|
Name of medicine
|
Lyxumia
|
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)
|
Name of medicine
|
Zaltrap
|
INN
|
aflibercept
|
Marketing-authorisation applicant
|
Sanofi-Aventis
|
Therapeutic indication
|
Treatment of metastatic colorectal cancer
|
More information
|
Summary of opinion for Zaltrap
|
Re-examination of opinion for new medicine
Name of medicine
|
Istodax
|
INN
|
romidepsin
|
Marketing-authorisation holder
|
Celgene Europe Ltd
|
Therapeutic indication
|
Treatment of peripheral T-cell lymphoma
|
More information
|
Questions and answers on Istodax
|
Positive recommendations on extensions of therapeutic indications
Name of medicine
|
Intelence
|
INN
|
etravirine
|
Marketing-authorisation holder
|
Janssen-Cilag International N.V.
|
Therapeutic indication
|
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).
|
More information
|
Summary of opinion for Intelence
|
Name of medicine
|
Exjade
|
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
|
|
Name of medicine
|
Prevenar 13
|
INN
|
pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
|
Marketing-authorisation holder
|
Pfizer Ltd
|
Therapeutic indication
|
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.
|
More information
|
Summary of opinion for Prevenar 13
|
Name of medicine
|
Zytiga
|
INN
|
abiraterone
|
Marketing-authorisation holder
|
Janssen-Cilag International N.V.
|
Therapeutic indication
|
Zytiga is indicated with prednisone or prednisolone for:
|
More information
|
|
Recommendation on new contraindication
Name of medicine
|
Tachosil
|
INN
|
human fibrinogen / human thrombin
|
Marketing-authorisation holder
|
Nycomed Austria GmbH
|
Contraindications
|
TachoSil must not be applied intravascularly.
|
More information
|
Summary of opinion for Tachosil
|
Opinion on public health reviews
Questions and answers on review of the fibrin sealants Evicel and Quixil given by spray application
Recommended product information will be available later.
|
Re-examination of opinion on public health review
Calcitonin-containing medicines
|
Opinion on any scientific matter (Article 5(3))
Press release: European Medicines Agency completes review of protamine-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 November 2012 by the Name Review Group (NRG)
|
Organisational matters
|
European Medicines Agency (EMA), 16.11.2012 (tB.