The European Medicines Agency informs doctors that the currently recommended dose of DORIBAX for the treatment of nosocomial pneumonia may be not sufficient in severe cases. A letter for the attention of health professionals will be sent to prescribers informing them of these new recommendations.
The framework law of 29th March 2012 contains an adaptation of the tax system to finance the missions of the Federal Agency for Medicines and Health Products. These changes are in line with the new requirements for pharmacovigilance at the European level. Circulars 588 and 589 provide practical information about it.
A new version of the "Detailed guidance on the collection, verification and presentation of adverse event / reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)" was published in June 2011. More information on the way these guidelines will be put into practice in Belgium is now published in circular 586.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency continues to regularly evaluate all available data concerning the risk of serious bleeding following administration of Pradaxa. The benefit of this anticoagulant medicine continues to outweigh the risks, but the CHMP considers it necessary to give clearer recommendations for prescribers and patients to better control the risk of bleeding associated with the administration of this medicine.
The French authorities have reassessed the veterinary medicines used to prevent and / or combat ectoparasites (fleas and ticks), which have been authorized in France through the national marketing authorization procedure. A potential danger to children was highlighted if they have prolonged and repeated contact with a pet wearing an antiparasitic collar containing dimpylat, tertrachlorvinphos or propoxur. The Belgian authorities are waiting for a European decision on the matter and recommend caution.