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Quadramet (samarium [153Sm] lexidronam pentasodium) – Conditions or restrictions regarding supply and use - V10BX02

Updated on site: 09-Oct-2017

Medication nameQuadramet
ATC CodeV10BX02
Substancesamarium [153Sm] lexidronam pentasodium
ManufacturerCIS bio international

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

CIS bio international

Boîte Postale 32

F-91192 Gif-sur-Yvette cedex

France

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Pharmacovigilance system

The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Not applicable

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