European Medicines Agency - - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 2. May 2. 01. 2. This page lists the opinions adopted at the May 2. 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 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.
How sure are you of your geographical knowledge? Buzzfeed recently put Americans’ geographical knowledge to the test with a survey in which participants had to. Dear doctors, researchers, and colleagues, The main cause of death in Latvia just like a.
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 1. More information. Summary of opinion for Fycompa. Name of medicine. Inlyta. International non- proprietary name (INN)axitinib.
Dear Colleagues and Friends, On behalf of the European Society for Sexual Medicine (ESSM), the two French Associations of Sexology, AIUS (Association. The Bilderberg Group, Bilderberg conference, Bilderberg meetings or Bilderberg Club is an annual private conference of 120 to 150 people of the European and North.
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. Summary of opinion for Inlyta.
Name of medicine. Jentadueto. International non- proprietary name (INN)linagliptin / metformin. Marketing authorisation applicant. Boehringer Ingelheim International Gmb.
HTherapeutic 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. The treatment of adult patients with tumour- induced hypercalcaemia. More information. Summary of opinion for Zoledronic acid Medac.
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(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. Herpes Dating Site Australia Immigration more. More information.
Summary of opinion for Osseor. Free One Night Stands Dating. Summary of opinion for Protelos. Name of medicine. Votrient. International non- proprietary name (INN)pazopanib. Marketing authorisation holder. Glaxo 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 1. Efficacy and safety has only been established in certain STS histological tumour subtypes.
More information. Summary of opinion for Votrient Name of medicine. Zonegran. International non- proprietary name (INN)zonisamide. Marketing authorisation holder.
Eisai 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 information. Summary of opinion for Zonegran.
Safety update of centrally authorised medicine. Outcome of review of centrally authorised medicine related to manufacturing issue. Outcome of harmonisation referrals.