What DaTSCAN contains
The active substance is ioflupane 123I. Each ml of solution contains ioflupane 123I 74 MBq at reference time 0.07 to 0.13 gml of ioflupane. The other ingredients are acetic acid, sodium acetate, ethanol and water for injections.
What DaTSCAN looks like and contents of the pack
DaTSCAN is a 2.5 or 5 ml colourless solution for injection, supplied in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GE Healthcare Limited
Little Chalfont
Bucks HP7 9NA
United Kingdom
Manufacturer:
GE Healthcare B.V.
Den Dolech 2
NL-5612 AZ, Eindhoven
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien GE Healthcare BVBA Kouterveldstraat 20 BE-1831 Diegem TélTel 32 0 2 719 7410 Lietuva GE Healthcare co Nycomed Lithuania Seimyniskiu 3 LT-2005 Vilnius Tel. 370 68 726 753
LuxembourgLuxemburg GE Healthcare BVBA Kouterveldstraat 20 BE-1831 Diegem BelgiëBelgiqueBelgien TélTel 32 0 2 719 7410 GE Healthcare South Central Europe Handels GmbH Representative Office Bulgaria 36 Dragan Tsankov blvd, World Trade Centre, Office B405-406, Sofia 1040 . 3592 973 3174
eská republika Magyarország GE Healthcare South Central Europe Handels GE Healthcare South Central Europe GmbH Branch Office Czech Republic Vyskocilova 14221a CZ 140 28 Praha 4 Tel 420 224 446 179 Handels GmbH Representative Office Hungary Akron u. 2 H-2040 Budaörs Tel 36 23 410 412
Danmark GE Healthcare AS Huginsvej 8 DK-3400 Hillerød Tlf 45 70 2222 03 Malta Pharma-Cos Ltd. Pharma-Cos House Triq C. Portanier MT Santa Venera HMR 11 Tel 356 21441 870
Deutschland GE Healthcare Buchler GmbH Co. KG Gieselweg 1 D-38110 Braunschweig Tel 49 0 5 307 93 00 Norge GE Healthcare AS Nycoveien 1-2 NO-0401 Oslo Tlf 47 23 18 50 50
Eesti GE Healthcare Estonia OÜ Mustamäe tee 46 EE - 10621 Tallinn Tel 372 6260 061 Nederland GE Healthcare B.V. De Rondom 8 NL-5612 AP, Eindhoven Tel 31 0 40 299 10 00
GE Healthcare A.E. 139 GR 141 21 . 30 210 805 08 64 Österreich GE Healthcare Handels GmbH Europlaza Gebäude E Wienerbergstrasse 41 Technologiestrasse 10 A-1120 Wien Tel 43 0 1 97272-0
España GE Healthcare Bio-Sciences, S.A. Polska GE Healthcare South Central Europe
C Gobelas, 35-37 28023 Madrid Tel 34 91 663 25 00 Handels GmbH Representative Office Poland 2, Stawki PL-00 193 Warszawa Tel. 48 22 6356886611
France GE Healthcare SA 11 avenue Morane Saulnier F-78140 Vélizy Villacoublay Tél 33 1 34 49 54 54 Portugal Satis GE Healthcare Edifico Ramazzotti Av. Do Forte n 6-6A 2790-072 Carnaxide Tel 351 214251352
Ireland GE Healthcare Limited Amersham Place Little Chalfont HP7 9NA - UK Tel 44 0 1494 54 40 00 România GE Healthcare South Central Europe Handels GmbH Representative Office Str.Navodari No.42 Sc.2 et.2 014108 Bucharest Tel 0040 21 2321153
Ísland Icepharma Lynghálsi 13 IS-110 Reykjavik Sími 354 540 8000 Slovenija Higiea d.o.o Blatnica 10 SI-1236 Trzin Tel 386 1 589 722125
Italia GE Healthcare S.r.l. Via Galeno 36 I-20126 Milano Tel 39 02 26001 111 Slovenská republika GE Healthcare South Central Europe Handels GmbH Branch Office Slovakia Florianske nám 2 SK-811 07 Bratislava Tel 421 2 5542 5948
Phadisco Ltd 185 CY-2235 357 22 715000 SuomiFinland Oy GE Healthcare Bio-Sciences Ab Kuortaneenkatu 2 FIN-00510 Helsinki PuhTel 358 10 39411
Latvija General Electric International Inc. Meza Str.4 Riga, LV-1048 Tel 371 780 7086 Sverige GE Healthcare AB Solna Strandväg 98 S-171 54 Solna Tel 46 0 8 559 504 00
United Kingdom
GE Healthcare Limited Amersham Place
Little Chalfont HP7 9NA-UK Tel: +44 (0) 1494 54 40 00
This leaflet was last approved in MM/YYYY