List of nationally authorised medicinal products
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1 27 January 2016 EMA/194278/2016 Procedure Management and Committees Support Active substance: Gadoteric acid (IV and intravascular formulations) 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 Product Name (in MRP/DCP National Authorisation MAH of product in the member Member State where authorisation country) Authorisation number Number state product is authorised Dotagita DE/H/3604/001/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotagita DE/H/3604/001/DC Agfa Healthcare Imaging Agents Gmbh France Dotagita DE/H/3604/001/DC Agfa Healthcare Imaging Agents Gmbh Estonia Dotagita DE/H/3604/001/DC BE Agfa Healthcare Imaging Agents Gmbh Belgium Dotagita DE/H/3604/001/DC LT/1/14/3608/ Agfa Healthcare Imaging Agents Gmbh Lithuania Dotagita Dotagita DE/H/3604/001/DC DE/H/3605/001/DC DE/H/3604/001/DC DE/H/3605/001/DC DE/H/3851/001/DC 7007/2014/ /2014/ Agfa Healthcare Imaging Agents Gmbh Agfa Healthcare Imaging Agents Gmbh Dotagita DE/H/3851/001/DC Agfa Healthcare Imaging Agents Gmbh Spain Romania Germany Dotagita DE/H/3851/001/DC PL 33127/0005 Agfa Healthcare Imaging Agents Gmbh United Kingdom Dotamulti DE/H/3605/001/DC Agfa Healthcare Imaging Agents Gmbh Italy Italy Austria Finland Sweden Denmark EMA/194278/2016 Page 2/6
3 1716/95/ /10/ /2009/ /2009/ /2009/ Greece Romania Luxembourg France France A. Martins & Fernandes, S.A. Portugal /1328/97-A/C Czech Republic 48/1328/97-B/C A. Martins & Fernandes, S.A. Portugal Spain EMA/194278/2016 Page 3/6
4 Norway BE BE BE BE BE BE BE BE OGYI-T-9156/01 OGYI-T-9156/02 OGYI-T-9156/03 OGYI-T-9156/04 OGYI-T-9156/05 PA 0686/003/002 PA 0686/003/005 UP/I /09-01/166 UP/I /11-02/07 LT/1/14/3509/001 LT/1/14/3509/002 LT/1/14/3509/003 LT/1/14/3509/004 LT/1/14/3509/005 LT/1/14/3509/006 LT/1/14/3509/ /0501/13-S 48/0502/13-S 48/0503/13-S Pharmacol D.O.O. Belgium Hungary Ireland Croatia Lithuania Latvia Poland Cyprus Slovakia EMA/194278/2016 Page 4/6
5 RVG RVG RVG RVG RVG LT/1/14/3509/008 LT/1/14/3509/009 LT/1/14/3509/010 Dotaspin Gadoteerzuur NL/H/2028/001 NL/H/2028/002 NL/H/2028/003 NL/H/2028/001 NL/H/2028/002 NL/H/2028/ RVG RVG RVG Nederland Bv Germany Estonia Netherlands Lithuania Germany Netherlands Bulgaria 12308/0017 United Kingdom 12308/0016 Dotagita 0,5 mmol/ml DE/H/3604/01/DC BE Agfa Healthcare Imaging Agents Gmbh Belgium Dotagita 0,5 mmol/ml DE/H/3604/01/DC BE Agfa Healthcare Imaging Agents Gmbh Belgium Dotagita 0,5 mmol/ml DE/H/3604/01/DC BE Agfa Healthcare Imaging Agents Gmbh Belgium Dotagita 0,5 mmol/ml DE/H/3604/01/DC BE Agfa Healthcare Imaging Agents Gmbh Belgium Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh France Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh France Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh France EMA/194278/2016 Page 5/6
6 Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh France Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh France Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh France Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh France Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotagita 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotamulti 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotamulti 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy Dotamulti 0,5 mmol/ml DE/H/3604/01/DC Agfa Healthcare Imaging Agents Gmbh Italy EMA/194278/2016 Page 6/6
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