The European Medicines Agency (EMEA) has reviewed the available information on the two cases of status epilepticus with myoclonus reported in two girls vaccinated with the cervical cancer vaccine Gardasil.. The Committee for Medicinal Products for Human Use (CHMP) of the EMEA considers that the cases are unlikely to be related to vaccination with Gardasil. The CHMP is recommending that vaccination with Gardasil should continue in accordance with national vaccination programmes in Member States. Around three million girls in Europe have been vaccinated with this vaccine since it was first authorised.
European Medicines Agency (EMEA) recommends adding a contraindication to the summary of product characteristics and public information leaflet for aliskiren (Rasilez only is marketed in Belgium). Rasilez and any aliskiren-containing medicine must not be used in patients who have experienced angioedema when taking aliskiren in the past. Moreover, patients who develop signs of angioedema should stop treatment and seek medical attention.
The European Medicines Agency (EMEA) recommends the suspension of the European marketing authorization for Raptiva (efalizumab) from Serono because of safety concerns including the occurrence of progressive multifocal leukoencephalopathy in patients with psoriasis taking the medicine. RAPTIVA is not marketed in Belgium.
The presence of a prion protein associated with variant Creutzfeldt-Jakob disease (vCJD) was discovered in the United Kingdom during the autopsy in the spleen of a patient with hemophilia. The patient was treated in the 1990s, particularly with factor VIII from different batches, one being made from a pool of plasma including that of a donor who developed symptoms of vCJD 6 months after donating plasma. In Belgium no clotting factor made from this pool of plasma has been used.
Circular 530 of the Federal Agency for Medicines and Health Products (FAMHP) gives instructions to marketing authorization holders for medicines for human and veterinary use on the application of Royal Decree (RD) of 21 January 2009 laying down the fees for the submission of a periodic safety update report (PSUR). This RD was published in the “Moniteur belge” on 29.01.2009 and entered into force on 08.02.2009.