GADOVIST

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

Active ingredients

The drug GADOVIST contains one active pharmaceutical ingredient (API):

1 Gadobutrol UNII 1BJ477IO2L - GADOBUTROL

Gadobutrol is a gadolinium-based, hydrophilic, macrocyclic, electrically neutral contrast agent used in contrast-enhanced MRI (CE-MRI). Read about Gadobutrol

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
GADOVIST Solution for injection in prefilled syringe/cartridge	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
V08CA09	Gadobutrol	V Various → V08 Contrast media → V08C Magnetic resonance imaging contrast media → V08CA Paramagnetic contrast media
Discover more medicines within V08CA09

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 538902602151316, 538918120028803
Country: CA	Health Products and Food Branch	Identifier(s): 02241089
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 29969-08-11
Country: EE	Ravimiamet	Identifier(s): 1133109, 1133110, 1345700, 1345711, 1359198, 1359200, 1380631, 1380642, 1380653, 1380664, 1380675, 1380686, 1380697, 1380709, 1380710, 1662645, 1662656, 1796485, 1796609, 1796610, 1796621, 1796665, 1800649, 1800650, 1800661, 1800672
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 63535, 63898
Country: FR	Base de données publique des médicaments	Identifier(s): 62143724, 62409751, 64755150, 67259654
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 121337, 234135, 386070, 386073, 90617, 90619, 90621
Country: HK	Department of Health Drug Office	Identifier(s): 51750, 57330
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-640080282, HR-H-860656850
Country: JP	医薬品医療機器総合機構	Identifier(s): 7290416A1022, 7290416G1025, 7290416G2021, 7290416G3028
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1012552, 1012553, 1054116, 1054117, 1054118, 1054119, 1054120, 1054121, 1059675, 1059676, 1059677, 1059678, 1059679, 1059680, 1059682, 1059683, 1059684, 1059685, 1059686, 1059687, 1059688, 1059689, 1059690, 1059691, 1073494, 1073495, 1076612, 1076613, 1076614, 1076615, 1076845, 1077357, 1077358, 1078163, 1078164, 1078647, 1078648, 1078649, 1078650, 1078651, 1078652, 1078653, 1078654, 1078655, 1078656, 1078657, 1078658, 1078659, 1086397
Country: MT	Medicines Authority	Identifier(s): MA1354/00101, MA1354/00102
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 10704
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100104096
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64838001, W64838002, W64838003, W64838004, W64838005, W64838006, W64838007, W64839001, W64839002, W64839003
Country: SG	Health Sciences Authority	Identifier(s): 12399P, 13807P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699546772438, 8699546772445, 8699546773428, 8699546778638
Country: ZA	Health Products Regulatory Authority	Identifier(s): 34/28/0384, 34/28/0385, 34/28/0386, 34/28/0387