Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 May 2012

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25/05/2012

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 May 2012

This page lists the opinions adopted at the May 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.

This month's highlights introduce changes based on feedback from journalists and other stakeholders over the last seven months:

  • the CHMP highlights now lists therapeutic indications for opinions for new medicines and for extensions of indications;
  • the annex on new marketing authorisation has been disbanded. This information is available on the European public assessment report (EPAR) page (to view the latest marketing authorisations, select 'View All' and sort by date);
  • procedural announcements are now published as news items on the homepage and under news for industry.

The Agency publishes a new page following each month's CHMP meeting.


Positive opinions on new medicines

Name of medicineBretaris Genuair / Eklira Genuair
International non-proprietary name (INN)aclidinium bromide
Marketing authorisation applicantAlmirall, S.A.
Therapeutic indicationMaintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease.
More information

Summary of opinion for Bretaris Genuair

Summary of opinion for Eklira Genuair

 

Name of medicineFycompa
International non-proprietary name (INN)perampanel
Marketing authorisation applicantEisai Europe Ltd
Therapeutic indicationAdjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
More informationSummary of opinion for Fycompa

 

Name of medicineInlyta
International non-proprietary name (INN)axitinib
Marketing authorisation applicantPfizer Ltd
Therapeutic indicationTreatment of adult patients with advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine.
More informationSummary of opinion for Inlyta

 

Name of medicineJentadueto
International non-proprietary name (INN)linagliptin / metformin
Marketing authorisation applicantBoehringer Ingelheim International GmbH
Therapeutic indicationTreatment of adult patients with type 2 diabetes mellitus: Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin. Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
More informationSummary of opinion for Jentadueto

 

Name of medicineKalydeco
International non-proprietary name (INN)ivacaftor
Marketing authorisation applicantVertex Pharmaceuticals (UK) Ltd
Therapeutic indicationTreatment of cystic fibrosis in patients age 6 years and older who have a G551D mutation in the CFTR gene.
More informationSummary of opinion for Kalydeco
Press releaseEuropean Medicines Agency recommends first-in-class medicine for treatment of cystic fibrosis

 

Name of medicineNovothirteen
International non-proprietary name (INN)catridecacog
Marketing authorisation applicantNovo Nordisk A/S
Therapeutic indicationLong term prophylactic treatment of bleeding in patients 6 years and above with congenital factor XIII A-subunit deficiency.
More informationSummary of opinion for Novothirteen


Positive opinions on new generic medicines

Name of medicineZoledronic acid Medac
International non-proprietary name (INN)zoledronic acid
Marketing authorisation applicantmedac Gesellschaft für klinische Spezialpräparate mbH
Therapeutic indicationPrevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. The treatment of adult patients with tumour-induced hypercalcaemia.
More informationSummary of opinion for Zoledronic acid Medac


Positive opinions on extensions of therapeutic indications 

Name of medicineOsseor / Protelos
International non-proprietary name (INN)strontium ranelate
Marketing authorisation holderLes Laboratoires Servier
Therapeutic indication
(changes in bold)
Treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral and hip fractures. Treatment of osteoporosis in men at increased risk of fracture.
More information

Summary of opinion for Osseor

Summary of opinion for Protelos

 

Name of medicineVotrient
International non-proprietary name (INN)pazopanib
Marketing authorisation holderGlaxo Group Ltd
Therapeutic indication
(changes in bold)

Renal cell carcinoma - Votrient is indicated in adults for the first line treatment of advanced renal cell carcinoma and for patients who have received prior cytokine therapy for advanced disease.

Soft tissue sarcoma (STS) - Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft tissue sarcoma who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes.

More informationSummary of opinion for Votrient

 

Name of medicineZonegran
International non-proprietary name (INN)zonisamide
Marketing authorisation holderEisai Ltd
Therapeutic indication
(changes in bold)
Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation in adult patients.
More informationSummary of opinion for Zonegran


Safety update of centrally authorised medicine

Name of medicineINNMarketing authorisation holder

Pradaxa

Press release: European Medicines Agency updates patient and prescriber information for Pradaxa

Questions and answers on the review of bleeding risk with Pradaxa (dabigatran etexilate)

dabigatran etexilate mesilateBoehringer Ingelheim International GmbH


Outcome of review of centrally authorised medicine related to manufacturing issue

Name of medicineINNMarketing authorisation holder

MabThera

Press release: European Medicines Agency confirms positive benefit-risk balance of MabThera

rituximabRoche Registration Ltd


Outcome of harmonisation referrals

Name of medicineINNMarketing authorisation holder
Flolan and associated namesepoprostenolGSK group of companies
Tavanic and associated nameslevofloxacinSanofi-Aventis group of companies
Zinnat and associated namescefuroxime axetilGSK group of companies
Zinacef and associated namescefuroxime axetilGSK group of companies


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 during the May 2012 CHMP meeting
Organisational matters


Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore users are asked to check the page regularly.

Contact point:

Monika Benstetter or Sabine Haubenreisser
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu