The Federal Agency for Medicines and Health Products (FAMHP) is passing on information published by the Directorate General Crisis Center of the Federal Public Department of the Interior (IBZ) on the validity of iodine tablets distributed in 1999 and 2002 to residents of risk zones around nuclear sites. These tablets remain fully valid and effective until the end of April 2011 despite exceeding the expiry date printed on the packaging.
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Prepulsid (cisapride): final stop of the distribution
The firm Janssen-Cilag, holder of the marketing authorization of Prepulsid (cisapride), informed FAMHP that this medicine used to treat serious disorders of gastric motility, is no longer available in Belgium from April 30, 2011. This follows the stopping of its marketing in 2004 for safety issues, followed by the "Prepulsid Patient Access Program" to give the remaining stock of Prepulsid available to patients who responded little or not to the other treatments. Currently, there is no more reason to continue or initiate a treatment with Prepulsid.
Veterinary medicines : partnership with the British and Irish authorities for the assessment of type II variation files
The FAMHP joined the English (Veterinary Medicines Directorate) and Irish (Irish Medicines Board) authorities in their proposed partnership ("Partnership Initiative") for the evaluation of the change of the marketing authorisation (MA) file (known as type II variation) of veterinary medicines. Resource sharing between partners in terms of assessment will have a positive impact on the management of these dossiers addressed at national level.
Fabrazyme: new treatment recommendations
The FAMHP published in 2009 and 2010 communiqués relating to the supply shortage of Cerezyme and Fabrazyme and measures to take about the treatment of the patients concerned. New recommendations regarding Fabrazyme are made by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), for the attention of specialised physicians in treating patients with Fabry disease (a disease due to an enzyme deficiency). These physicians are regularly informed of developments and recommendations in this regard.
Avandia, Avandamet (rosiglirazone): withdrawal from the market
The firm GlaxoSmithKline, the marketing autorisation (MA) holder for Avandia and Avandamet, decided to remove these medicines from the Belgian market following the recommendation of the European Medicines Agency (EMA) to suspend their marketing authorisation, due to the increased cardiovascular risk associated with their use.
Communication 572 about the "contact-point”
Communication 572 of the FAMHP reminds readers of the existence and the working methods of the “contact-point” and its role in implementing the regulations in the fight against excessive promotion of medicines and medical devices.
Recommendation of the EMA to limit the indication of fibrates in second-line treatment of lipid disorders
For several years the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has been regularly reviewing the risk-benefit balance of medicines containing a fibrate because of the limited evidence of their long-term benefits in reducing cardiovascular risk. The CHMP considers that the balance remains positive but the indication of these medicines should be limited to second-line treatment of lipid disorders (except for patients who have severe hyperlipidemia or who are intolerant to statins and who might benefit from treatment with a fibrate).
Invirase (saquinavir): reduction of starting dose
Following the evaluation of arrhythmia risk in patients treated with Invirase (saquinavir), the European Medicines Agency (EMA) believes that the risk-benefit balance of this medicine remains positive. The EMA nevertheless recommends that patients taking Invirase for the first time should take a reduced dose during the first week of treatment.
Belgian participation in PANGEA III, an international operation fighting against the online sale of counterfeit and illegal medicines.
From 5th to 12th October 2010 there was once again coordinated international action, targeting the online sale of counterfeit medicines and other illegal medicines in the world: Pangea III. This action was coordinated by Interpol, World Customs Organization (WCO), the Permanent Forum on International Pharmaceutical Crime (PFIPC), the Heads of Medicines Agencies Working Group of Enforcement Officers (HMA WGEO), the pharmaceutical industry and the electronic payments industry.
"Miracle Mineral Solution" or "MMS": warning
Following questions from the press and warnings from various foreign authorities, the Federal Agency for Medicines and Health Products (FAMHP), the Federal Agency for the Safety of the Food Chain (FASFC) and the Federal Public Service (FPS) Health are issuing a warning about a product called Mineral Miracle Solution or "MMS", presented on the Internet as a miracle product for various diseases.