the treatment of disease related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibit
in combination with Xtandi (enzalutamide) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated
From 6 to 13 November 2023, the FAMHP is taking part in the worldwide #MedSafetyWeek campaign, a cooperation between medicines regulators from more than 80 countries and several non-governmental organisations. The goal is to raise awareness about the importance of reporting side effects of medicines.
During its November 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that the available evidence does not support a causal association between the glucagon-like peptide-1 (GLP-1) receptor agonists - exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and thyroid cancer.
Remember to consult your doctor or pharmacist if you have concerns about a suspected adverse effect after taking a medicine.
Consult them immediately if you experience an adverse reaction that seems serious or is indicated as serious in the package leaflet.
as monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy
Glucagon-like peptide-1 (GLP-1) analogues are in increasing demand worldwide. The limited availability of some of these drugs will last in Belgium until June 2024. Experts from the FAMHP's Unavailability Task Force issue the following recommendations.
Licence or registration holders of category 1 and 2 registered substances should contact FPS Finance - Customs and Excise, Precursors cell at da.investigation.precursors@minfin.fed.be for destruction of raw materials/ semi-finished products/ rejected batches.
There are no special requirements for the other categories (3 and 4). Medicines must be destroyed in accordance with the applicable waste legislation.