27 January 2016 EMA/186911/2016 Procedure Management and Committees Support
List of nationally authorised medicinal products
Active substance: gadoteridol
Procedure no.: PSUSA/00001507/201504
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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
Product Name (in MRP/DCP Authorisation National Authorisation MAH of product in the member Member State where authorisation number Number state product is authorised country)
Prohance 029055011 $ 029055023 $ Bracco Imaging Italia Srl Italy 029055035 $ 029055047 $ 029055050 $ 029055062 $ 029055074 $ 029055086 $ 029055124 Prohance 0953/05088286 Bracco Imaging Deutschland Luxembourg Gmbh Prohance 1-22234 Bracco Imaging S.P.A. Austria Prohance 11428 Bracco International Bv Finland Prohance 11795 Bracco International Bv Sweden Prohance 14447/0001 $ 14447/0002 Bracco International Bv United Kingdom Prohance 15357 Bracco International Bv Denmark Prohance 337 850-3 $ 337 852-6 $ Bracco Imaging France France 337853.2 $ 337854.9 Prohance 3400930011867 $ Bracco Imaging France France 3400930011881 $ 3400930011904 $ 3400930011928 $ 3400930011973 $ 3400930011980 Prohance 350.827-1 $ 350828.8 $ Bracco Imaging France France 350829.4 Prohance 46599.00.00 Bracco Imaging Deutschland Germany Gmbh Prohance 48/0226/00-S Bracco Imaging Deutschland Slovakia Gmbh Prohance 48/151/00-A/C Bracco Imaging Deutschland Czech Republic
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Product Name (in MRP/DCP Authorisation National Authorisation MAH of product in the member Member State where authorisation number Number state product is authorised country)
Gmbh Prohance 48/151/00-B/C Bracco Imaging Deutschland Czech Republic Gmbh Prohance 60.377 $ 64.474 Bracco International Bv Spain Prohance 8320 Bracco Imaging Deutschland Poland Gmbh Prohance 95-2346 Bracco International Bv Norway Prohance BE199902 $ BE199936 $ Bracco Imaging Deutschland Belgium BE199945 $ BE199954 $ Gmbh BE274267 $ BE430412 Prohance PA 0788/001/001 $ PA Bracco International Bv Ireland 0788/001/002 $ PA 0788/001/003 $ PA 0788/001/004 Prohance RVG16528 Bracco Imaging Deutschland Netherlands Gmbh
List of nationally authorised medicinal products EMA/186911/2016 Page 3/3