Oct 26, 2017 - Germanium(Ge-68)tetraklorid/Gallium(Ga-. 68)triklorid Eckert & Ziegler, 0,74 â 1,85 GBq, radionukli
26 October 2017 EMA/727988/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products Active substance(s): germanium (68Ge) chloride / gallium (68Ga) chloride
Procedure No.: PSUSA/00010364/201703
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
MRP/DCP
National
MAH of product in the
Member State
Authorisation
Authorisation
member state
where product is
number
Number
GalliaPharm 0,74 – 1,85 GBq Radionuklidgenerator
DK/H/2294/001
89872.00.00
GalliaPharm, 0,74 – 1,85 GBq, radionuclidegenerator Germanium(Ge-68)tetraklorid/Gallium(Ga68)triklorid Eckert & Ziegler, 0,74 – 1,85 GBq, radionuklidgenerator GalliaPharm, 0,74–1,85 GBq, radionuklidgenerator
DK/H/2294/001
RVG 113484
DK/H/2294/001
49222
DK/H/2294/001
13-9477
Galliapharm, radionuclide generator
DK/H/2294/001
52231
Germanio cloruro (68Ge)/Gallio cloruro (68Ga) GalliaPharm 0,74 – 1,85 GBq generatore di radionuclidi GalliaPharm, 0,74 à 1,85 GBq, générateur radiopharmaceutique GalliaPharm, 0,74 –1,85 GBq, Radionuklidgenerator
DK/H/2294/001
042707012
DK/H/2294/001
BE468133
DK/H/2294/001
BE468133
GalliaPharm, 0,74 – 1,85 GBq, radionuclidegenerator GalliaPharm, 0,74–1,85 GBq, radionuklidigeneraattori GalliaPharm, 0,74–1,85 GBq, radionuklidgenerator
DK/H/2294/001
BE468133
DK/H/2294/001
31367
DK/H/2294/001
31367
GalliaPharm 0,74 - 1,85 GBq Radionuklidgenerator
DK/H/2294/001
436047
GalliaPharm 0,74 -1,85 GBq generador de radionúclido GalliaPharm, 0,74 – 1,85 GBq, generator radionuklidu Germanio cloruro (68Ge)/Gallio cloruro (68Ga) GalliaPharm 0,74 – 1,85 GBq generatore di radionuclidi Germanio cloruro (68Ge)/Gallio cloruro (68Ga)
DK/H/2294/001
79102
DK/H/2294/001
22311
DK/H/2294/001
042707036
DK/H/2294/001
042707024
Product Name (in authorisation country)
EMA/727988/2017
authorised ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH
DE
ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH
NO
ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH ECKERT & ZIEGLER RADIOPHARMA GMBH
BE
ECKERT & ZIEGLER
IT
NL SE
DK IT
BE BE FI FI AT ES PL IT
Page 2/3
Product Name (in authorisation country)
GalliaPharm 0,74 – 1,85 GBq generatore di radionuclidi Germanio cloruro (68Ge)/Gallio cloruro (68Ga) GalliaPharm 0,74 – 1,85 GBq generatore di radionuclidi GalliaPharm, 0,74 à 1,85 GBq, générateur de radionucléides
EMA/727988/2017
MRP/DCP
National
MAH of product in the
Member State
Authorisation
Authorisation
member state
where product is
number
Number
authorised RADIOPHARMA GMBH
DK/H/2294/001
042707048
ECKERT & ZIEGLER RADIOPHARMA GMBH
IT
DK/H/2294/001
34009 550 052 4 7
ECKERT & ZIEGLER RADIOPHARMA GMBH
FR
Page 3/3
