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12 and 17 December 2018: final date for submitting dossiers during the Christmas holidays

During the Christmas holidays, the FAMHP will be closed from Monday 24 December 2018 until Tuesday 1 January 2019 included.

Operation PANGEA XI: Belgian customs and the FAMHP seize 141 packages containing over 28,000 illicit or counterfeit products

The FAMHP, in collaboration with Belgian customs, took part in the international Operation PANGEA XI from 9 to 15 October 2018. This operation, coordinated by INTERPOL, specifically targets the interception of illicit and counterfeit medicinal products and devices. In Belgium, inspections were carried out at the Zaventem and Bierset airports.

Public consultation: clinical trial on a genetically modified medicinal product against hemophilia B

Give your opinion on a clinical trial with a genetically modified medicinal product for the treatment of hemophilia B. The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product AMT-061 from the company uniQure biopharma B.V. The purpose of this trial is to demonstrate the efficacy of AMT-061 for the treatment of moderate to severe haemophilia B and to further describe its safety aspects. The public consultation runs from 17 October 2018 to 17 November 2018 inclusive.

Give your opinion on two clinical trials with a genetically modified medicinal product for the treatment of spinal muscular atrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on two clinical trials with the genetically modified medicinal product AVXS-101 from the company AveXis, Inc. The purpose of the trials is to evaluate the safety, tolerability and efficacy of AVXS-101 for the treatment of spinal muscular atrophy. The public consultation runs from 17 October 2018 to 17 November 2018 inclusive.

European medicines authorities take further action in ongoing review of sartans

European medicines authorities have placed the Chinese company Zheijiang Huahai under increased supervision and the Indian company Aurobindo Pharma is no longer allowed to supply irbesartan to EU member states.

New ESVAC report: European monitoring of antibiotic use in animals. Reduced usage but Belgium must continue to make efforts

The European Medicines Agency (EMA) published the eighth ESVAC (European Surveillance of Veterinary Antimicrobial Consumption) report on the sale of antibacterials for veterinary use in 2016.

Good manufacturing practices for medicinal products available in French and Dutch

Until today, the good manufacturing practices (GMP) for medicinal products were only available in English. As of now, the GMP will be available in French and Dutch on the FAMHP website.

Product recall of batches of Durex Natural Feeling Extra Lubricated and Durex Real Feeling latex-free polyisoprene condoms

The FAMHP would like to remind consumers and patients about a recall by Reckitt Benckiser of Durex Natural Feeling Extra Lubricated condoms and Durex Real Feeling latex-free polyisoprene condoms. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.

Safety information concerning Philips ear thermometers

The FAMHP would like to relay safety information concerning two types of ear thermometer to consumers and patients. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.

A website as an annual report: the FAMHP innovates by publishing its 2017 results in digital version

In 2017, the 460 employees of the FAMHP closed more than 8,000 applications for marketing authorisation for medicines, carried out no less than 2,200 inspections and investigations, analysed more than 10,000 reports of adverse effects, reactions and incidents, and answered more than 250 press questions.

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