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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 May 2012
London, UK (May 25, 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:
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the CHMP highlights now lists therapeutic indications for opinions for new medicines and for extensions of indications;
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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);
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procedural announcements are now published as news items on the homepage and under news for industry.
The Agency publishes a new page following each months‘ CHMP meeting.
Positive opinions on new medicines
|
Name of medicine |
Bretaris Genuair / Eklira Genuair |
|
International non-proprietary name (INN) |
aclidinium bromide |
|
Marketing authorisation applicant |
Almirall, S.A. |
|
Therapeutic indication |
Maintenance 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 medicine |
Fycompa |
|
International non-proprietary name (INN) |
perampanel |
|
Marketing authorisation applicant |
Eisai Europe Ltd |
|
Therapeutic indication |
Adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. |
|
More information |
|
Name of medicine |
Inlyta |
|
International non-proprietary name (INN) |
axitinib |
|
Marketing authorisation applicant |
Pfizer Ltd |
|
Therapeutic indication |
Treatment of adult patients with advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine. |
|
More information |
|
Name of medicine |
Jentadueto |
|
International non-proprietary name (INN) |
linagliptin / metformin |
|
Marketing authorisation applicant |
Boehringer Ingelheim International GmbH |
|
Therapeutic indication |
Treatment 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 information |
|
Name of medicine |
Kalydeco |
|
International non-proprietary name (INN) |
ivacaftor |
|
Marketing authorisation applicant |
Vertex Pharmaceuticals (UK) Ltd |
|
Therapeutic indication |
Treatment of cystic fibrosis in patients age 6 years and older who have a G551D mutation in the CFTR gene. |
|
More information |
|
|
Press release |
European Medicines Agency recommends first-in-class medicine for treatment of cystic fibrosis |
|
Name of medicine |
NovoThirteen |
|
International non-proprietary name (INN) |
catridecacog |
|
Marketing authorisation applicant |
Novo Nordisk A/S |
|
Therapeutic indication |
Long term prophylactic treatment of bleeding in patients |
|
More information |
Positive opinions on new generic medicines
|
Name of medicine |
Zoledronic acid Medac |
|
International non-proprietary name (INN) |
zoledronic acid |
|
Marketing authorisation applicant |
medac Gesellschaft für klinische Spezialpräparate mbH |
|
Therapeutic indication |
Prevention 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 information |
Positive opinions on extensions of therapeutic indications
|
Name of medicine |
Osseor / Protelos |
|
International non-proprietary name (INN) |
strontium ranelate |
|
Marketing authorisation holder |
Les Laboratoires Servier |
|
Therapeutic indication |
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 medicine |
Votrient |
|
International non-proprietary name (INN) |
pazopanib |
|
Marketing authorisation holder |
Glaxco Group Ltd |
|
Therapeutic indication |
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 information |
|
Name of medicine |
Zonegran |
|
International non-proprietary name (INN) |
zonisamide |
|
Marketing authorisation holder |
Eisai Ltd |
|
Therapeutic indication |
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 information |
Safety update of centrally authorised medicine
|
Name of medicine |
INN |
Marketing authorisation holder |
|
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 mesilate |
Boehringer Ingelheim International GmbH |
Outcome of review of centrally authorised medicine related to manufacturing issue
|
Name of medicine |
INN |
Marketing authorisation holder |
|
Press release: European Medicines Agency confirms positive benefit-risk balance of MabThera |
rituximab |
Roche Registration Ltd |
Outcome of harmonisation referrals
|
Name of medicine |
INN |
Marketing authorisation holder |
|
epoprostenol |
GSK group of companies |
|
|
levofloxacin |
Sanofi-Aventis group of companies |
|
|
cefuroxime axetil |
GSK group of companies |
|
|
cefuroxime axetil |
GSK group of companies |
Other updates
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Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures |
|
Opinions on safety variations |
|
Guidelines and concept papers adopted during the May 2012 CHMP meeting |
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Organisational matters |
European Medicines Agency (EMA), 25.05.2012 (tB)