26 October 2017 EMA/691325/2017 Human Medicines Evaluation Division Active substance: Technetium (99mTc) pertechnetate Procedure no.: PSUSA/00002866/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 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.
Poltechnet 8,0-175 GBq radionuklidgenerator Полтехнет 8,0-175 GBq радионуклиден генератор Poltechnet, 8,0-175 GBq, radionuklidový Poltechnet 8,0-175 GBq Poltechnet 8 175 GBq, radionuklidgenerator Poltechnet 8,0-175 GBq, generator radionuklidu Poltechnet 8,0-175 GBq generador de radionúclido Poltechgen 8,0-175 GBq radionuklidų generatorius Poltechnet 8,0-175 GBq generator de radionuclizi Poltechnet 8-175 GBq radionuklidni generator MONTEK 10-40 GBq MONTEK 10-40 GBq generator de radionuclizi МОНТЕК 10-40 GBq Радионуклиден генератор National Number SE/H/1365/001 53595 NARODOWE CENTRUM SE/H/1365/001 20150115 NARODOWE CENTRUM SE/H/1365/001 88/232/15-C NARODOWE CENTRUM SE/H/1365/001 436188 NARODOWE CENTRUM SE/H/1365/001 50676 NARODOWE CENTRUM SE/H/1365/001 22500 NARODOWE CENTRUM SE/H/1365/001 79993 NARODOWE CENTRUM SE/H/1365/001 LT/1/15/3742/001 NARODOWE CENTRUM LT SE/H/1365/001 8017/2015/01 NARODOWE CENTRUM RO SE/H/1365/001 H/16/02180/001 NARODOWE CENTRUM SI DK/H/1741/001 78187.00.00 MONROL EUROPE SRL DE DK/H/1741/001 8901/2016/01 MONROL EUROPE SRL RO DK/H/1741/001 II-14210 MONROL EUROPE SRL BG DK BG CZ AT SE PL ES EMA/691325/2017 Page 2/11
National Number Montek, radionuclide DK/H/1741/001 02246 MONROL EUROPE SRL DK generator MONTEK 10-40 GBq DK/H/1741/001 7751/31.1.2012 MONROL EUROPE SRL GR γεννήτρια ραδιονουκλιδίου DRYTEC not available 8323 GE HEALTHCARE LIMITED NO DRYTEC 2.5-100 GBq Драйтек 2,5-100 GBq радионуклиден генератор Drytec (Radionuklidový 2,5-100 GBq) Drytec, radionuclide generator Drytec Sterile Technetium radionukliidgeneraator Drytec radionuklidigeneraattori not available PA 0240/021/001 GE HEALTHCARE LIMITED IE not available II-15028/27.11.2006 GE HEALTHCARE LIMITED BG not available 88/136/83-C GE HEALTHCARE LIMITED CZ not available DK R 1138 GE HEALTHCARE LIMITED DK not available 474205 GE HEALTHCARE LIMITED EE not available 11213 GE HEALTHCARE LIMITED FI not available OGYI-T-9098/01 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/05 GE HEALTHCARE LIMITED HU EMA/691325/2017 Page 3/11
National Number not available OGYI-T-9098/06 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/07 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/09 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/10 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/08 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/11 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/12 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/13 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/14 GE HEALTHCARE LIMITED HU EMA/691325/2017 Page 4/11
National Number not available OGYI-T-9098/15 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/03 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/02 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/16 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/17 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/18 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/04 GE HEALTHCARE LIMITED HU DRYTEC not available 65.219 GE HEALTHCARE BIO- DRYTEC 2.5-100 GBq, radionuklidgenerator SCIENCES, S.A.U. not available PL 00221/0106 GE HEALTHCARE LIMITED UK not available 80028 GE HEALTHCARE LIMITED SE ES EMA/691325/2017 Page 5/11
National Number DRYTEC, générateur de not available 34009 564 4541 7 GE HEALTHCARE SAS FR Molybdène (99Mo) / Technétium (99mTc) Drytec, radionuklīdu not available 01-0399 GE HEALTHCARE LIMITED LV ģenerators DRYTEC 2,5-100 GBq not available LT/1/2000/1621/001 GE HEALTHCARE LIMITED LT radionuklidų generatorius Drytec, 2,5-100 GBq not available RVG 16220 GE HEALTHCARE B.V. NL Drytec, 2,5-100 GBq, not available 10137 GE HEALTHCARE LIMITED PL generator radionuklidu DRYTEC TECNÉCIO-99M not available 4205480 GE HEALTHCARE LIMITED PT GERADOR ESTÉRIL DRYTEC 2,5-100 GBq not available 28635.00.00 GE HEALTHCARE BUCHLER DE GMBH & CO. KG DRYTEC not available 25026/6-4-2009 GE HEALTHCARE LIMITED GR Drytec rádionuklidový Drytec 2,5 100 GBq générateur radiopharmaceutique Drytec 2,5-100GBq generator de radionuclizi not available 88/0195/08-S GE HEALTHCARE LIMITED SK not available 6953/2014/01 GE HEALTHCARE LIMITED RO EMA/691325/2017 Page 6/11
Drytec 2,5 100 GBq générateur radiopharmaceutique National Number not available 2016060150 GE HEALTHCARE BVBA LU not available 2016060150 GE HEALTHCARE BVBA LU DRYTEC not available 8323 GE HEALTHCARE LIMITED NO DRYTEC 2.5-100 GBq Драйтек 2,5-100 GBq радионуклиден генератор Drytec (Radionuklidový 2,5-100 GBq) Drytec, radionuclide generator Drytec Sterile Technetium radionukliidgeneraator Drytec radionuklidigeneraattori not available PA 0240/021/001 GE HEALTHCARE LIMITED IE not available II-15028/27.11.2006 GE HEALTHCARE LIMITED BG not available 88/136/83-C GE HEALTHCARE LIMITED CZ not available DK R 1138 GE HEALTHCARE LIMITED DK not available 474205 GE HEALTHCARE LIMITED EE not available 11213 GE HEALTHCARE LIMITED FI not available OGYI-T-9098/01 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/05 GE HEALTHCARE LIMITED HU EMA/691325/2017 Page 7/11
National Number not available OGYI-T-9098/06 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/07 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/09 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/10 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/08 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/11 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/12 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/13 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/14 GE HEALTHCARE LIMITED HU EMA/691325/2017 Page 8/11
National Number not available OGYI-T-9098/15 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/03 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/02 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/16 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/17 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/18 GE HEALTHCARE LIMITED HU not available OGYI-T-9098/04 GE HEALTHCARE LIMITED HU DRYTEC not available 65.219 GE HEALTHCARE BIO- DRYTEC 2.5-100 GBq, radionuklidgenerator SCIENCES, S.A.U. not available PL 00221/0106 GE HEALTHCARE LIMITED UK not available 80028 GE HEALTHCARE LIMITED SE ES EMA/691325/2017 Page 9/11
National Number DRYTEC, générateur de not available 34009 564 4541 7 GE HEALTHCARE SAS FR Molybdène (99Mo) / Technétium (99mTc) Drytec, radionuklīdu not available 01-0399 GE HEALTHCARE LIMITED LV ģenerators DRYTEC 2,5-100 GBq not available LT/1/2000/1621/001 GE HEALTHCARE LIMITED LT radionuklidų generatorius Drytec, 2,5-100 GBq not available RVG 16220 GE HEALTHCARE B.V. NL Drytec, 2,5-100 GBq, not available 10137 GE HEALTHCARE LIMITED PL generator radionuklidu DRYTEC TECNÉCIO-99M not available 4205480 GE HEALTHCARE LIMITED PT GERADOR ESTÉRIL DRYTEC 2,5-100 GBq not available 28635.00.00 GE HEALTHCARE BUCHLER DE GMBH & CO. KG DRYTEC not available 25026/6-4-2009 GE HEALTHCARE LIMITED GR Drytec rádionuklidový Drytec 2,5 100 GBq générateur radiopharmaceutique Drytec 2,5-100GBq generator de radionuclizi not available 88/0195/08-S GE HEALTHCARE LIMITED SK not available 6953/2014/01 GE HEALTHCARE LIMITED RO EMA/691325/2017 Page 10/11
Drytec 2,5 100 GBq générateur radiopharmaceutique National Number not available 2016060150 GE HEALTHCARE BVBA LU not available 2016060150 GE HEALTHCARE BVBA LU EMA/691325/2017 Page 11/11