Shifting towards needs-driven healthcare: highlights from the Belgian high-level conference

On 17 and 18 April, the Federal Agency for Medicines and Health Products (FAMHP), the National Institute for Health and Disability Insurance (NIHDI) and the Health Care Knowledge Centre (KCE) organised a high-level conference on health-related needs as drivers for healthcare policy and innovation. This conference was organised in the context of the Belgian presidency of the Council of the EU. The aim is to establish a research and innovation ecosystem that focuses on the most pressing health needs.

Sotatercept

Active substance MK-7962
Holder Merck Sharp & Dohme LLC, A subsidiary of Merck & Co.

BALVERSA

Active substance erdafitinib
Holder Janssen-Cilag NV
Status Running
Indication This compassionate use program (CUP) is intended to provide early access to erdafitinib for the adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harboring susceptible FGFR3 genetic alterations with disease progression during or following at least one lin

Fintepla for DS

Active substance Fenfluramine (as fenfluramine hydrochloride)
Holder UCB PHARMA NV
Status Running
Indication Fintepla for the treatment of patients with Dravet syndrome who completed the open label study ZX008-1900 (EP0215; EudraCT number 2019-001331-31), or the open label study titled “Fenfluramine als anti-epilepticum bij Dravet syndroom en epileptische encephalopathieën

Fintepla for LGS

Active substance Fenfluramine (as fenfluramine hydrochloride)
Holder UCB PHARMA NV
Status Running
Indication Fintepla for the treatment of patients with Lennox-Gastaut syndrome who completed the open label study ZX008-1900 (EP0215, EudraCT number 2019-001331-31), or the open label study titled “Fenfluramine als anti-epilepticum bij Dravet syndroom en epileptische encephalo

Warning of counterfeit ivermectin tablets sold via social media

The FAMHP and Sciensano are warning about counterfeit ivermectin tablets that are being used for self-medication against COVID-19. Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day.

Marketing authorisation holders: mandatory update of contact details in product information for reporting adverse reactions to the FAMHP

The current postbox address of the FAMHP is no longer applicable. The contact details for reporting adverse reactions to the FAMHP should be changed by marketing authorisation holders in the product information of medicinal products for human use as soon as possible.
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