A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
GE Healthcare B.V.
Den Dolech 2
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
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT