Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012

News 20/07/2012

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 medicineAdcetris
International non-proprietary name (INN)brentuximab vedotin
Marketing-authorisation applicantTakeda Global Research and Development Centre (Europe) Ltd
Therapeutic indicationTreatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma
More information PDF iconSummary of opinion for Adcetris

Name of medicineDacogen
International non-proprietary name (INN)decitabine
Marketing-authorisation applicantJanssen-Cilag International N V
Therapeutic indicationTreatment of acute myeloid leukaemia
More information PDF iconSummary of opinion for Dacogen

Name of medicineGlybera
International non-proprietary name (INN)alipogene tiparvovec
Marketing-authorisation applicantuniQure biopharma B.V.
Therapeutic indicationHyperlipoproteinaemia type I

More information

Press release: European Medicines Agency recommends first gene therapy for approval

PDF iconSummary of opinion for Glybera

Name of medicineXalkori
International non-proprietary name (INN)crizotinib
Marketing-authorisation applicantPfizer Ltd
Therapeutic indicationTreatment of lung cancer
More information PDF iconSummary of opinion for Xalkori

Negative recommendation on new medicine

Name of medicineIstodax
International non-proprietary name (INN)romidepsin
Marketing-authorisation applicantCelgene 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 medicineHumira
International non-proprietary name (INN)adalimumab
Marketing-authorisation holderAbbott 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 PDF iconSummary of opinion for Humira

Name of medicinePrezista
International non-proprietary name (INN)darunavir
Marketing-authorisation holderJanssen-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 PDF iconSummary of opinion for Prezista

Opinion on safety review of centrally authorised medicines

Name of medicineINNMarketing-authorisation holder
PDF iconAlli, Mircera, Pegasys, Tamiflu, Xeloda, Xenical
orlistat, methoxy polyethylene glycol-epoetin beta, peginterferon alfa-2a, oseltamivir, capecitabineRoche Registration Limited

Name of medicineINNMarketing-authorisation holder
PDF iconConbriza, Torisel

PDF iconPecFent

bazedoxifene, temsirolimus


Pfizer Ltd

Archimedes Development Ltd

Recommendation on new contra-indications

Name of medicineINNMarketing-authorisation holder
PDF iconOzurdex dexamethasoneAllergan Pharmaceuticals Ireland
PDF iconPradaxa dabigatran etexilate mesilateBoehringer Ingelheim International GmbH

Opinions on safety reviews of non-centrally authorised medicines

Name of medicine
Calcitonin-containing medicines

Press release: European Medicines Agency recommends limiting long-term use of calcitonin medicines

Opinions on arbitration procedures

Name of medicineINNMarketing-authorisation holder
Glimepirida Parke-DavisglimepirideParke-Davis-Produtos Farmaceuticos, Lda
Mometasone Furoate Sandozmometasone furoateSandoz B.V.

Opinions on Article 36 referral procedures – for the protection of public health

Name of medicineINN
Preflucelinfluenza vaccine, purified antigen

Other updates

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

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