Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012
News
Human
This page lists the opinions adopted at the July 2012 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.
Users can view the main opinions adopted at the meeting, along with information on referral procedures, in a clear tabular format. Users can click on the links within the page to read individual press releases and more detailed information about the opinions.
The Agency publishes a new page following each month's CHMP meeting.
Last meeting of the Pharmacovigilance Working Party
The CHMP heard the last report from the chair of the Pharmacovigilance Working Party. This working party has ceased to exist following the establishment of the new Pharmacovigilance Risk Assessment Committee (PRAC). The CHMP thanked the members of the Pharmacovigilance Working Party for their work and contribution to the protection of public health in Europe.
Positive recommendations on new medicines
| Name of medicine | Adcetris |
|---|---|
| International non-proprietary name (INN) | brentuximab vedotin |
| Marketing-authorisation applicant | Takeda Global Research and Development Centre (Europe) Ltd |
| Therapeutic indication | Treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma |
| More information | CHMP summary of positive opinion for Adcetris |
| Name of medicine | Dacogen |
|---|---|
| International non-proprietary name (INN) | decitabine |
| Marketing-authorisation applicant | Janssen-Cilag International N V |
| Therapeutic indication | Treatment of acute myeloid leukaemia |
| More information | CHMP summary of positive opinion for Dacogen |
| Name of medicine | Glybera |
|---|---|
| International non-proprietary name (INN) | alipogene tiparvovec |
| Marketing-authorisation applicant | uniQure biopharma B.V. |
| Therapeutic indication | Hyperlipoproteinaemia type I |
|
More information |
Press release: European Medicines Agency recommends first gene therapy for approval |
| Name of medicine | Xalkori |
|---|---|
| International non-proprietary name (INN) | crizotinib |
| Marketing-authorisation applicant | Pfizer Ltd |
| Therapeutic indication | Treatment of lung cancer |
| More information | CHMP summary of positive opinion for Xalkori |
Negative recommendation on new medicine
| Name of medicine | Istodax |
|---|---|
| International non-proprietary name (INN) | romidepsin |
| Marketing-authorisation applicant | 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) |
Positive recommendations on extensions of therapeutic indications
| Name of medicine | Humira |
|---|---|
| International non-proprietary name (INN) | adalimumab |
| Marketing-authorisation holder | Abbott Laboratories Ltd |
| Therapeutic indication (changes in bold) |
Moderate Crohn's disease Humira is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies All other indications remain unchanged. |
| More information | CHMP post-authorisation summary of positive opinion for Humira |
| Name of medicine | Prezista |
|---|---|
| International non-proprietary name (INN) | darunavir |
| Marketing-authorisation holder | Janssen-Cilag International NV |
| Therapeutic indication (changes in bold) |
Prezista, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients as well as antiretroviral therapy (ART)-experienced paediatric patients from the age of 3 years and at least 15 kg body weight |
| More information | CHMP post-authorisation summary of positive opinion for Prezista |
Opinion on safety review of centrally authorised medicines
| Name of medicine | INN | Marketing-authorisation holder |
|---|---|---|
| Questions and answers on the review of centrally authorised medicines with ingredients manufactured at Roche Carolina Inc., Florence, United States | orlistat, methoxy polyethylene glycol-epoetin beta, peginterferon alfa-2a, oseltamivir, capecitabine | Roche Registration Limited |
| Name of medicine | INN | Marketing-authorisation holder |
|---|---|---|
| Questions and answers on the review of Conbriza (bazedoxifene), PecFent (fentanyl) and Torisel (temsirolimus) |
bazedoxifene, temsirolimus fentanyl |
Pfizer Ltd Archimedes Development Ltd |
Recommendation on new contra-indications
| Name of medicine | INN | Marketing-authorisation holder |
|---|---|---|
| CHMP post-authorisation summary of positive opinion for Ozurdex | dexamethasone | Allergan Pharmaceuticals Ireland |
| CHMP post-authorisation positive summary of opinion for Pradaxa | dabigatran etexilate mesilate | Boehringer Ingelheim International GmbH |
Opinions on safety reviews of non-centrally authorised medicines
Opinions on arbitration procedures
| Name of medicine | INN | Marketing-authorisation holder |
|---|---|---|
| Glimepirida Parke-Davis | glimepiride | Parke-Davis-Produtos Farmaceuticos, Lda |
| Mometasone Furoate Sandoz | mometasone furoate | Sandoz B.V. |
Opinions on Article 36 referral procedures – for the protection of public health
| Name of medicine | INN |
|---|---|
| Preflucel | influenza vaccine, purified antigen |