Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2012
News
Human
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 |
CHMP summary of positive opinion for Bexsero Press release: European Medicines Agency recommends approval of first vaccine for |
| Name of medicine | Lyxumia |
|---|---|
| INN | lixisenatide |
| Marketing-authorisation applicant | Sanofi-Aventis |
| Therapeutic indication | Treatment of type-2 diabetes mellitus |
| More information | CHMP summary of positive opinion for Lyxumia |
| Name of medicine | Zaltrap |
|---|---|
| INN | aflibercept |
| Marketing-authorisation applicant | Sanofi-Aventis |
| Therapeutic indication | Treatment of metastatic colorectal cancer |
| More information | CHMP summary of positive 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 the refusal of the marketing authorisation for Istodax (romidepsin) - Outcome of re-examination |
Positive recommendations on extensions of therapeutic indications
| Name of medicine | Intelence |
|---|---|
| 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 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 | CHMP post-authorisation summary of positive 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 non-transfusion- dependent thalassaemia syndromes aged 10 years and older. |
| More information | CHMP post-authorisation summary of positive opinion for Exjade |
| Name of medicine | Prevenar 13 |
|---|---|
| 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 | CHMP post-authorisation summary of positive opinion for Prevenar 13 |
| Name of medicine | Zytiga |
|---|---|
| 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 | CHMP post-authorisation summary of positive opinion for Zytiga |
Recommendation on new contraindication
| Name of medicine | TachoSil |
|---|---|
| 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 | CHMP post-authorisation summary of positive opinion for TachoSil (II-0041) |
Opinion on public-health review
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Recommended product information will be available later. |
Re-examination of opinion on public health review
Opinion on any scientific matter (Article 5(3))
Other updates