Welcome to the website of the Federal Agency for Medicines and Health Products
Role of the FAMHP
We ensure the quality, safety and efficacy of medicines and health products in clinical development and on the market.
NEWS
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Rosiglitazone: a question mark about the safety
The European Medicines Agency (EMA) is reassessing the hypoglycemic medicines containing rosiglitazone used in the treatment of type 2 diabetes, following the publication of new studies on the cardiovascular risk associated with their use. The Committee for Medicinal Products for Human Use (CHMP) of the EMA, at its next plenary meeting (19-22 July 2010), will decide whether it is appropriate to withdraw, suspend or modify the marketing authorisation of these medicines.
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Recommendations of the European Medicines Agency (EMA) regarding radiopharmaceuticals
In response to the shortage of Technetium-99m (Tc-99m) on the European market, the EMA organized on February 4-5th 2010 the workshop "Current use and future needs of radiopharmaceuticals labelled with radionuclides produced in reactors and possible alternatives". The workshop primarily addressed the current use and future role of radionuclides that are produced in reactors (in particular Tc-99m) and which are being used for diagnostic or therapeutic purposes in nuclear medicine.
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Ethanol-containing medicines: precautions and recommendations
The Commission for Medicinal Products for Human Use, the Commission for homeopathic medicines and the Commission for Herbal Medicinal Products issued recommendations on medicines - in particular medicines for children - containing ethanol (alcohol) as an excipient. The FAMHP approves these recommendations aimed to protect patients and especially children. Applicants / marketing authorisation/registration holders of such medicines are invited to take account of these recommendations.
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Clinical Trials: Circular 567
The Federal Agency for Medicines and Health Products (FAMHP) wishes to inform sponsors of clinical trials and experimental drug manufacturers, hospital pharmacists, hospital head doctors, hospital directors about the publication of a new circular on the activities of producing experimental medicines.
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