Omjjara

Active substance Momelotinib
Holder GlaxoSmithKline Pharmaceuticals S.A./N.V.
Status Running
Indication  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

Talzenna

Active substance talazoparib
Holder Pfizer NV/SA
Status Running
Indication 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
Public documents

PRAC November 2023 – Conclusion regarding available evidence not supporting link between the glucagon-like peptide-1 (GLP-1) receptor agonists and thyroid cancer

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.

Columvi

Active substance glofitamab
Holder nv Roche sa
Status closed
Indication 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
Public documents Approbation
 

Epcoritamab

Active substance Epcoritamab
Holder AbbVie Belgium SA/NV
Status Runing
Indication Third line and subsequent lines of treatment (3rd +) Relapse/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Public documents Approbation
 

Limited availability of GLP-1 analogues: recommendations for medical doctors (specialists), (hospital) pharmacists and patients

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.

Destruction

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.

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