A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Advanced Accelerator Applications Technopole de l’Aube
14 rue Gustave Eiffel
10430 Rosières près Troyes France
Advanced Accelerator Applications S.r.l
Via Piero Maroncelli 40/42
47014 Meldola (FC)
Instituto Tecnológico PET, SA.
C/Manuel Bartolome Cossio 10
Seibersdorf Laboratories, Seibersdorf
Seibersdorf Labor GmbH
Grundstuck Nr. 482/2 EZ98 KG
Laboratoires CYCLOPHARMA, Marseille Technopôle de Château Gombert
Rue Louis Leprince Ringuet 13013 Marseille
Advanced Accelerator Applications Ibérica S.L. Polígono Industrial la Cuesta 3, Parcelas 1 y 2 50100 La Almunia de Doña Godina
AAA, Colleretto Giacosa (TO)
Advanced Accelerator Applications S.r.l.
Via Ribes 5
10010 Colleretto Giacosa (TO)
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to restricted medical prescription.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
•Periodic safety update reports
The marketing authorisation holder shall submit the first periodic safety update report for this product within six months following authorisation. Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
•Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
•At the request of the European Medicines Agency;
•Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of
an important (pharmacovigilance or risk minimisation) milestone being reached.
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
•Additional risk minimisation measures
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where VIZAMYL is marketed, at launch and after launch, all physicians who are expected to use VIZAMYL have access to a training course in order to ensure accurate and reliable interpretation of the PET images.
The training course for healthcare professionals should contain the following key elements:
•Information on amyloid pathology in Alzheimer Disease; relevant information on VIZAMYL as an
•Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the binary read methodology.
•The material should include VIZAMYL PET demonstration cases with correct PET scan interpretation by an experienced reader;
Expertise and qualification of trainers in both electronic and