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DaTSCAN (ioflupane (123l)) – Conditions or restrictions regarding supply and use - V09AB03

Updated on site: 06-Oct-2017

Medication nameDaTSCAN
ATC CodeV09AB03
Substanceioflupane (123l)
ManufacturerGE Healthcare Limited

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

GE Healthcare B.V.

Den Dolech 2

NL-5612 AZ, Eindhoven

The Netherlands

B.CONDITIONS OR RESTRICTIONS REARDING 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

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive

2001/83/EC and any subsequent updates published on the European medicines web-portal.

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

Not applicable

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