Vizamyl™ (Flutemetamol F 18 Injection)
Electronic Reader Training Program
The European health authorities have imposed certain conditions to the marketing of the medicinal product Vizamyl. The risk minimisation activities in Belgium and Luxembourg, which include this information, have been taken to ensure the safe and effective use of Vizamyl (RMP version 4.0/2022).
This electronic training program contains important information to ensure accurate and reliable interpretation of PET images when using Vizamyl.
Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information, including full up-to-date list of adverse reactions (appendix V), available on the website www.fagg.be, section "PACKAGE INSERT and SmPC of a medicinal product".
Reporting adverse events:
For Belgium: Healthcare professionals are asked to report side effects associated with the use of Vizamyl to the Pharmacovigilance Department of the Federal Agency for Medicines and Health Products (FAMHP). Reporting can be done by preference online via www.eenbijwerkingmelden.be or through the paper “yellow sheet" available in the public pharmacy and via the Folia Pharmacotherapeutica. The yellow sheet can be sent by post to the address FAGG – Vigilance department - Galileelaan 5/03, 1210 BRUSSELS or electronically to e-mail: firstname.lastname@example.org
For Luxembourg: Centre Régional de Pharmacovigilance de Nancy ou Division de la pharmacie et des médicaments de la Direction de la santé. Site internet : www.guichet.lu/pharmacovigilance
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