List of nationally authorised medicinal products

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1 26 October 2017 EMA/691325/2017 Human Medicines Evaluation Division Active substance: Technetium (99mTc) pertechnetate Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 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 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 GBq radionuklidni generator MONTEK GBq MONTEK GBq generator de radionuclizi МОНТЕК GBq Радионуклиден генератор National Number SE/H/1365/ NARODOWE CENTRUM SE/H/1365/ NARODOWE CENTRUM SE/H/1365/001 88/232/15-C NARODOWE CENTRUM SE/H/1365/ NARODOWE CENTRUM SE/H/1365/ NARODOWE CENTRUM SE/H/1365/ NARODOWE CENTRUM SE/H/1365/ NARODOWE CENTRUM SE/H/1365/001 LT/1/15/3742/001 NARODOWE CENTRUM LT SE/H/1365/ /2015/01 NARODOWE CENTRUM RO SE/H/1365/001 H/16/02180/001 NARODOWE CENTRUM SI DK/H/1741/ MONROL EUROPE SRL DE DK/H/1741/ /2016/01 MONROL EUROPE SRL RO DK/H/1741/001 II MONROL EUROPE SRL BG DK BG CZ AT SE PL ES EMA/691325/2017 Page 2/11

3 National Number Montek, radionuclide DK/H/1741/ MONROL EUROPE SRL DK generator MONTEK GBq DK/H/1741/ / MONROL EUROPE SRL GR γεννήτρια ραδιονουκλιδίου DRYTEC not available 8323 GE HEALTHCARE LIMITED NO DRYTEC 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/ 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 GE HEALTHCARE LIMITED EE not available 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

4 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

5 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 GE HEALTHCARE BIO- DRYTEC GBq, radionuklidgenerator SCIENCES, S.A.U. not available PL 00221/0106 GE HEALTHCARE LIMITED UK not available GE HEALTHCARE LIMITED SE ES EMA/691325/2017 Page 5/11

6 National Number DRYTEC, générateur de not available GE HEALTHCARE SAS FR Molybdène (99Mo) / Technétium (99mTc) Drytec, radionuklīdu not available 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 GE HEALTHCARE B.V. NL Drytec, 2,5-100 GBq, not available GE HEALTHCARE LIMITED PL generator radionuklidu DRYTEC TECNÉCIO-99M not available GE HEALTHCARE LIMITED PT GERADOR ESTÉRIL DRYTEC 2,5-100 GBq not available GE HEALTHCARE BUCHLER DE GMBH & CO. KG DRYTEC not available 25026/ 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

7 Drytec 2,5 100 GBq générateur radiopharmaceutique National Number not available GE HEALTHCARE BVBA LU not available GE HEALTHCARE BVBA LU DRYTEC not available 8323 GE HEALTHCARE LIMITED NO DRYTEC 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/ 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 GE HEALTHCARE LIMITED EE not available 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

8 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

9 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 GE HEALTHCARE BIO- DRYTEC GBq, radionuklidgenerator SCIENCES, S.A.U. not available PL 00221/0106 GE HEALTHCARE LIMITED UK not available GE HEALTHCARE LIMITED SE ES EMA/691325/2017 Page 9/11

10 National Number DRYTEC, générateur de not available GE HEALTHCARE SAS FR Molybdène (99Mo) / Technétium (99mTc) Drytec, radionuklīdu not available 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 GE HEALTHCARE B.V. NL Drytec, 2,5-100 GBq, not available GE HEALTHCARE LIMITED PL generator radionuklidu DRYTEC TECNÉCIO-99M not available GE HEALTHCARE LIMITED PT GERADOR ESTÉRIL DRYTEC 2,5-100 GBq not available GE HEALTHCARE BUCHLER DE GMBH & CO. KG DRYTEC not available 25026/ 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

11 Drytec 2,5 100 GBq générateur radiopharmaceutique National Number not available GE HEALTHCARE BVBA LU not available GE HEALTHCARE BVBA LU EMA/691325/2017 Page 11/11

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