News FAMHP

Wholesalers will be allowed to distribute medicinal products that are not authorised in Belgium in our country if they meet a special need in Belgium due to a critical unavailability, as determined by the Federal Agency for Medicines and Health Products (FAMHP).

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is going to evaluate data relating to suicidal ideation and behaviour.

The FAMHP authorises the use of the immunological veterinary medicinal product Hepizovac (suspension for injection from the company CZ Vaccines S.A.U.) intended for cattle.

The PRAC recommends measures to minimise serious outcomes of known side effect with the painkiller metamizole and formulated new recommendations to minimise the risk of meningioma with medicines containing medroxyprogesterone acetate. During its September 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended measures to minimise serious outcomes of known side effect with painkiller metamizole and formulated new recommendations to minimise the risk of meningioma with medicines containing medroxyprogesterone acetate.

Because of a delay in the planned deliveries of the Zypadhera medicinal product (intramuscular (IM) olanzapine with prolonged disease) by the Cheplapharm Registration company, supplies in Belgium are limited. The availability of these medicinal products is also limited in other European countries. Therefore, the experts of the Unavailability Task Force update the previous recommendations.

The medicinal product Pegasys® 180µg, solution for injection, will have limited availability in Belgium until June 2025. Experts of the task force Unavailability recommend the following.

Since 1 February 2023, a withdrawal programme can be provided for outpatients taking benzodiazepines or Z-drugs. This programme is based on the magistral preparation of capsules following a doctor's prescription. The project, which was initially due to run for one year, has been extended until 31 December 2024.

The European Commission is considering allowing the use of electronic instructions for use for all devices for professional use. The Commission is therefore launching a survey for healthcare professionals.

The Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA), having analysed recent reports on diabetic ketoacidosis associated with Senvelgo use, now issues recommendations.

During its July 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency issued new recommendations for GLP-1 receptor agonists and agreed a direct healthcare professional communication for glatiramer acetate containing products.