GADOVIST

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

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 more about Gadobutrol

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
BR	Câmara de Regulação do Mercado de Medicamentos	538902602151316, 538918120028803
CA	Health Products and Food Branch	02241089
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	29969-08-11
EE	Ravimiamet	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
ES	Centro de información online de medicamentos de la AEMPS	63535, 63898
FR	Base de données publique des médicaments	62143724, 62409751, 64755150, 67259654
GB	Medicines & Healthcare Products Regulatory Agency	121337, 234135, 386070, 386073, 90617, 90619, 90621
HK	Department of Health Drug Office	51750, 57330
HR	Agencija za lijekove i medicinske proizvode	HR-H-640080282, HR-H-860656850
JP	医薬品医療機器総合機構	7290416A1022, 7290416G1025, 7290416G2021, 7290416G3028
LT	Valstybinė vaistų kontrolės tarnyba	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
MT	Medicines Authority	MA1354/00101, MA1354/00102
NZ	Medicines and Medical Devices Safety Authority	10704
PL	Rejestru Produktów Leczniczych	100104096
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64838001, W64838002, W64838003, W64838004, W64838005, W64838006, W64838007, W64839001, W64839002, W64839003
SG	Health Sciences Authority	12399P, 13807P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699546772438, 8699546772445, 8699546773428, 8699546778638
ZA	Health Products Regulatory Authority	34/28/0384, 34/28/0385, 34/28/0386, 34/28/0387