News FAMHP

Studies have suggested that clopidogrel (PLAVIX and generics) may be less effective in patients treated with a medicine of the class of proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole and rabeprazole: medicines used in treatment and prevention of stomach ulcers). New studies show that only omeprazole and esomeprazole may reduce blood levels of clopidogrel and reduce its effectiveness. The European Medicines Agency (EMA) is therefore making further recommendations on this subject.

The legislation provides the opportunity for doctors and dentists to prescribe medicines in INN. They can therefore ignore the different names and packages of medicines containing the same active ingredient, the same dose and same route of administration. In this matter pharmacists give advice about rational use of medicines, price comparison and choice of appropriate packaging. To help them in their mission, the Federal Agency for Medicines and Health Products (FAMHP) wrote a note to set in operation the "INN prescription” law. A file containing the different INN groups, provisionally in pdf format, is available on the website of the

DG Post of the Federal Agency for Medicines and Health Products (FAMHP) has taken new measures to expedite the renewal of registrations or MA for medicines for human use granted under the national procedure and thus reduce the backlog of these renewal dossiers

Supply problems which were discussed in the communiqué of 06/07/2009 concerning Cerezyme and Fabrazyme, as well as the communiqués of 18.08.2009 and 6.11.2009 concerning Cerezyme, are not yet fully resolved. The manufacturer Genzyme has updated the information relating to these supply problems and recommendations are made.

Following the recommendation of the European Medicines Agency (EMA) to suspend the marketing authorization of medicines containing sibutramine, the firm Abbott, at the request of the Federal Agency for Medicines and Health Products (FAMHP), withdrew Reductil from the market (the only medicine with sibutramine approved and marketed in Belgium) for security reasons. The FAMHP stresses the danger of buying online medicines with sibutramine.

The European Medicines Agency (EMEA) has reviewed the safety of sibutramine, a medicine against excessive weight. Based on available data it woud seem that the cardiovascular risks associated with the use of this medicine outweigh its benefits. The EMEA recommends the suspension of the marketing authorisation of all medicines containing sibutramine that are marketed in the European Union. In Belgium sibutramine is marketed under the name Reductil.rketing

The checker currently used in the FAMHP for technical validation of all submitted registration dossiers concerning medicines for human use has been adjusted to take account of restrictions and controls as specified in the "no e-CTD Electronic Submission” (Nees) and e-CTD submission.

The law of 23rd December 2009 containing various provisions on public health, which was published in the “Moniteur belge” of 29th December 2009, came into force on 8th January 2010. It contains, amongst other things, provisions which amend the law of 19th December 2008 concerning the acquisition and use of human body material intended for human medical applications or for scientific research.

The Vice-Prime Minister and Minister of Public Health, Laurette Onkelinx, announced on Monday 11/01/2010 at a press conference that the FAMHP now makes available on its website, for health (human or animal) professionals and for patients, the Summaries of Product Characteristics (SPC) and the package leaflets of medicinal products for human or veterinary use that are authorized and marketed in Belgium.