The paper narcotic drugs order forms will disappear: the FAMHP launches narcoreg.be, the online application for narcotic drugs order forms

In Belgium, any delivery or receipt of narcotic drugs and psychotropic substances must be reported to the FAMHP. From 1 September 2023, the new online application of the FAMHP, that replaces the paper narcotic drugs order forms, must be used for that purpose. A transition period has been set, starting 1 July 2023.

The FAMHP publishes its annual report 2022: packed with figures and results, special trends and highlighting our most important projects

Although the FAMHP's staff continued to feel the effects of the health crisis, in 2022 they were also able to complete many tasks that had been postponed due to the coronavirus crisis. Various “major” files were started, followed up or closed. For example, new initiatives were launched in collaboration with other national and European institutions to combat the shortage of medicines in Belgium and the European Union.

Livmarli

Active substance maralixibat chloride
Holder Mirum Pharmaceuticals International B.V.
Status Running
Indication treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older
Public documents Approbation

Nubeqa

Active substance darolutamide
Holder Bayer SA/NV
Status Closed
Indication Treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with ADT and docetaxel
Public documents

Nirogacestat

PRAC May 2023 – Restrictions on the use of fluoroquinolone antibiotics and new safety information for fluoroquinolone antibiotics and Gavreto

During its May 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), is reminding healthcare professionals that the use of fluoroquinolone antibiotics given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side effects. The PRAC discussed direct healthcare professional communications (DHPCs) containing important information on fluoroquinolone antibiotics and Gavreto.

Sarclisa

Active substance

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