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Vizamyl (flutemetamol (18F)) – Conditions or restrictions regarding supply and use - V09AX04

Updated on site: 10-Oct-2017

Medication nameVizamyl
ATC CodeV09AX04
Substanceflutemetamol (18F)
ManufacturerGE Healthcare Ltd

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

AAA, Troyes

Advanced Accelerator Applications Technopole de l’Aube

14 rue Gustave Eiffel

10430 Rosières près Troyes France

AAA, Forli

Advanced Accelerator Applications S.r.l

Via Piero Maroncelli 40/42

47014 Meldola (FC)

Italy

ITP, Madrid

Instituto Tecnológico PET, SA.

C/Manuel Bartolome Cossio 10

28040 Madrid

Spain

Seibersdorf Laboratories, Seibersdorf

Seibersdorf Labor GmbH

Grundstuck Nr. 482/2 EZ98 KG

2444 Seibersdorf

Austria

Laboratoires CYCLOPHARMA, Marseille Technopôle de Château Gombert

Rue Louis Leprince Ringuet 13013 Marseille

France

AAA, Zaragoza

Advanced Accelerator Applications Ibérica S.L. Polígono Industrial la Cuesta 3, Parcelas 1 y 2 50100 La Almunia de Doña Godina

Zaragoza Spain

AAA, Colleretto Giacosa (TO)

Advanced Accelerator Applications S.r.l.

Via Ribes 5

10010 Colleretto Giacosa (TO)

Italy

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 web-portal.

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 β-amyloid PET tracer, including the approved indication according to the SmPC, limitations of VIZAMYL use, interpretation errors, safety information and the results of clinical trials informing on the diagnostic use of VIZAMYL.

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; VIZAMYL-PET scans for self-assessment; and a self- qualification procedure to be offered to each trainee. Training should include a sufficient number of clearly positive and negative cases as well as intermediate level cases. Cases should be histopathologically confirmed, if possible.

Expertise and qualification of trainers in both electronic and in-person training should be ensured.

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