Any holder of Belgian marketing authorisation (MA) or registration of medicines for human or veterinary use must notify the Federal Agency for Medicines and Health Products (FAMHP) the name of the person responsible for pharmacovigilance. Circulars 544 and 545 are a reminder of that obligation and provide practical information about it.
European Medicines Agency (EMEA) makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents. In Belgium, they are marketed under the following names: Dotarem, Gadovist, Magnegita, Magnevist, Multihance, Omniscan, Optimark, Prohance et Vasovist.
pharma.be (General Association of Pharmaceuticals Manufacturers) and FeBelGen (Federation of Belgian generic drugs companies) are organising, in collaboration with the Federal Agency for Medicines and Health Products (FAMHP) an information session on how to manage applications for Marketing Authorisation for medicinal products for human use. This will take place on Friday 11 December at 1 pm in Sodehotel la Woluwe (Avenue E. Mounier 5, 1200 Brussels)
The firm GlaxoSmithKline has warned the Federal Agency for Medicines and Health Products (FAMHP) about supply shortages of the vaccine Infanrix Hexa. After evaluation of the dossier by the Advisory Commission, the FAMHP has authorized temporary importation of vaccines from another Member State. So the vaccine Infanrix Hexa should be available again in ONE centers and "Kind & Gezin" in the coming days.
Due to a supply shortage of Cerezyme, treatment recommendations for patients with Gaucher’s disease have been issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) and published in the communiqué of the FAMHP dated 18/08/2009. The situation returns to normal at the manufacturing site of Cerezyme. The recommendations have therefore been updated.