Circular 547 of the Federal Agency for Medicines and Health Products (FAMHP) reminds MA holders of medicines of the obligation to notify the FAMHP the date when they are placed on the market or are withdrawn. Circular 547 provides guidance on how data on the status of marketing in Belgium of medicines authorized by the European Commission (centralized procedure for obtaining an MA) must be communicated to the AFMPS.
The European Medicines Agency has started to receive data on H1N1 pandemic vaccines and the review began in July, with the commitment from the Committee for Medicinal Products for Human Use, to fast-track the review of data as vaccine manufacturers make them available.
Following review of all available information on a possible relationship between insulin analogues, in particular insulin glargine, and the risk of cancer, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the available data does not provide a cause for concern and that changes to the prescribing advice are therefore not necessary.
The Federal Agency for Medicines and Health Products (AFMPS) asked the company Sanofi-Aventis to temporarily stop the distribution of Rhinatiol Muco sugar-free cough syrup for children and remove a batch from the Belgian market awaiting the results of tests in progress. These are only precautionary measures.
The Federal Agency for Medicines and Health Products (FAMHP) wishes to draw your attention to the potential risk of products for skin whitening. This is following in-store controls it has conducted on African products in several cities in Belgium.
The Federal Agency for Medicines and Health Products (FAMHP) is passing on information published by the Directorate General Crisis Center of the Federal Public Service Interior (IBZ) on the validity of iodine tablets distributed to residents of risk zones around nuclear sites. These tablets distributed in 1999 and 2002 remain fully valid and effective at least until the end of October 2009.
The European Medicines Agency (EMEA) reviewed four studies designed to investigate a possible relationship between insulin analogues, in particular insulin glargine (Lantus) and the risk of cancer. The results of these studies are not consistent. A causal relationship therefore can be neither confirmed nor excluded. The EMEA continues the investigations in cooperation with the firm Sanofi-Aventis, the holder of the marketing authorization of Lantus. Patients being treated with insulin glargine are advised to continue their treatment as normal.
In anticipation of expected supply problems of Cerezyme and Fabrazyme over the next few months, the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommends that patients who are in greatest need of treatment are given priority access to these medicines.
The second annual report of the Federal Agency for Medicines and Health Products (FAMHP) presents an overview of its achievements in 2008, in the form of descriptive articles, interviews and figures. The FAMHP invites you to read this.