News FAMHP

Further to the bankruptcy of the company Denolin, some pharmacists have encountered problems in the supply of injectable ampoules Mephenon. The firm Sterop has taken up the marketing authorizations of this medicine. Therefore, the potential difficulties should be resolved by the end of July.

The Federal Agency for Medicines and Health Products (FAMHP) issued two press releases in March 2010 relating to the presence of non-pathogenic viral particles in batches of the vaccine Rotarix. The European Medicines Agency (EMEA) confirmed that the detected porcine circovirus type 1 (PCV-1) does not pose a health risk and the benefit / risk balance of Rotarix remains positive.

The European Medicines Agency (EMA) recommends keeping only the narcolepsy as an indication of modafinil-containing medicines. In Belgium only this indication is given in the summary of product characteristics (SPC) and in the patient information leaflet (PIL) of Provigil (the only modafinil-containing medicine approved and marketed in Belgium). In other member states other indications have been approved. They will be removed from the SPC and the PIL of those medicines.

The European Medicines Agency (EMA) has completed the reassessment of modified release (prolonged) oral opioids of level III (powerful analgesics) as classified by the World Health Organisation (WHO). The benefits of most of these drugs outweigh the risks. However, the marketing authorizations of opiates with a controlled-release system containing polymethyl-triethylcitrate should be suspended because of the risk of too quick a release of the active substance with an overdose after taking alcohol. Opioids of this type are currently authorized but are not marketed in Belgium.

The EMA confirms the positive benefit / risk balance of ketoprofen-containing medicines for topical use. Doctors who prescribe them and pharmacists who issue them are required to inform patients about the proper way to use these medicines. In Belgium only Fastum gel is approved and marketed. Currently this is freely available but, according to new recommendations from the EMA, it will soon be subject to medical prescription.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is examining all available data regarding the benefit / risk balance of rosiglitazone-containing medicines. Awaiting the outcome of this evaluation, scheduled for September 2010, prescribers are advised to strictly follow the recommendations of the summary of product characteristics (patients who may benefit from treatment, contra-indications and warnings).

The European Medicines Agency (EMA) is reassessing the hypoglycemic medicines containing rosiglitazone used in the treatment of type 2 diabetes, following the publication of new studies on the cardiovascular risk associated with their use. The Committee for Medicinal Products for Human Use (CHMP) of the EMA, at its next plenary meeting (19-22 July 2010), will decide whether it is appropriate to withdraw, suspend or modify the marketing authorisation of these medicines.

In response to the shortage of Technetium-99m (Tc-99m) on the European market, the EMA organized on February 4-5th 2010 the workshop "Current use and future needs of radiopharmaceuticals labelled with radionuclides produced in reactors and possible alternatives". The workshop primarily addressed the current use and future role of radionuclides that are produced in reactors (in particular Tc-99m) and which are being used for diagnostic or therapeutic purposes in nuclear medicine.

The Commission for Medicinal Products for Human Use, the Commission for homeopathic medicines and the Commission for Herbal Medicinal Products issued recommendations on medicines - in particular medicines for children - containing ethanol (alcohol) as an excipient. The FAMHP approves these recommendations aimed to protect patients and especially children. Applicants / marketing authorisation/registration holders of such medicines are invited to take account of these recommendations.

The Federal Agency for Medicines and Health Products (FAMHP) wishes to inform sponsors of clinical trials and experimental drug manufacturers, hospital pharmacists, hospital head doctors, hospital directors about the publication of a new circular on the activities of producing experimental medicines.