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 (RMA version 12/2020).
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 (FMHP). Reporting can be done by preference online via www.eenbijwerkingmelden.be or www.notifieruneffetindesirable.be or through the paper “yellow sheet" which is available upon request from the FAGG/AFMPS or which can be printed from their website. The completed yellow sheet can be sent by mail to the address FAGG - Vigilance department - PO Box 97 – 1000 Brussels, Madou, by fax on 02/528.40.01 or by e-mail to: email@example.com or firstname.lastname@example.org
For Luxembourg: au Centre Régional de Pharmacovigilance de Nancy, Bâtiment de Biologie Moléculaire et de Biopathologie (BBB), CHRU de Nancy – Hôpitaux de Brabois, Rue du Morvan, 54 511 VANDOEUVRE LES NANCY CEDEX; E-mail: email@example.com; Tél: (+33) 3 83 65 60 85/87, ou à la Direction de la Sante - Division de la Pharmacie et des Médicaments, 20, Rue de Bitbourg, L-1273 Luxembourg-Hamm; Tél: (+352) 2478 5592; E-mail: firstname.lastname@example.org.
Lien vers le formulaire de notification: https://guichet.public.lu/.../notification-effets-indesirables-medicaments
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