Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2012

News 16/11/2012

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 medicineBexsero
International non-proprietary name (INN)meningococcal group-B vaccine (rDNA, component, adsorbed)
Marketing-authorisation applicantNovartis Vaccines and Diagnostics S.r.l.
Therapeutic indicationActive immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B
More information

PDF iconSummary of opinion for Bexsero

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


Name of medicineLyxumia
INNlixisenatide
Marketing-authorisation applicantSanofi-Aventis
Therapeutic indicationTreatment of type-2 diabetes mellitus
More information PDF iconSummary of opinion for Lyxumia


Name of medicineZaltrap
INNaflibercept
Marketing-authorisation applicantSanofi-Aventis
Therapeutic indicationTreatment of metastatic colorectal cancer
More information PDF iconSummary of opinion for Zaltrap



Re-examination of opinion for new medicine

Name of medicineIstodax
INNromidepsin
Marketing-authorisation holderCelgene Europe Ltd
Therapeutic indicationTreatment of peripheral T-cell lymphoma
More information PDF iconQuestions and answers on Istodax



Positive recommendations on extensions of therapeutic indications

Name of medicineIntelence
INNetravirine
Marketing-authorisation holderJanssen-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 pretreated 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 PDF iconSummary of opinion for Intelence


Name of medicineExjade
INNdeferasirox
Marketing-authorisation holderNovartis Europharm Ltd
New therapeutic indicationExjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion- dependent thalassaemia syndromes aged 10 years and older.
More information PDF iconSummary of opinion for Exjade


Name of medicinePrevenar 13
INNpneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Marketing-authorisation holderPfizer 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 PDF iconSummary of opinion for Prevenar 13


Name of medicineZytiga
INNabiraterone
Marketing-authorisation holderJanssen-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 PDF iconSummary of opinion for Zytiga



Recommendation on new contraindication

Name of medicineTachoSil
INNhuman fibrinogen / human thrombin
Marketing-authorisation holderNycomed 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 PDF iconSummary of opinion for Tachosil



Opinion on public-health review

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


PDF iconQuestions 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

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
Start of community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
Overview of invented names reviewed in November 2012 by the Name Review Group (NRG)
PDF iconOrganisational matters

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