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.