DOTAREM

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

Active ingredients

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

1 Gadoteric acid UNII L0ND3981AG - GADOTERATE MEGLUMINE

Gadoteric acid has paramagnetic properties allowing MRI contrast enhancement. It has no specific pharmacodynamic activity and is biologically very inert. Read about Gadoteric acid

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
DOTAREM Solution for injection	Medicines and Medical Devices Safety Authority (NZ)	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
V08CA02	Gadoteric acid	V Various → V08 Contrast media → V08C Magnetic resonance imaging contrast media → V08CA Paramagnetic contrast media
Discover more medicines within V08CA02

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): 511000203154418, 511000204150416, 511000206153412, 511000209152417, 511021020006503, 511021020006603, 511021020006703
Country: CA	Health Products and Food Branch	Identifier(s): 02459329
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 29864-06-11
Country: EE	Ravimiamet	Identifier(s): 1619771, 1619782, 1619793, 1619805, 1619816, 1619861, 1619872, 1619894, 1619906, 1619917, 1826681, 1826692, 1826704
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 62165, 67489
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 001829, 003867, 009414, 062422, 062513, 119908, 389541, 402612, 572131, 572263, 572339
Country: FR	Base de données publique des médicaments	Identifier(s): 63078350, 69244971
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 299113, 299119, 299125, 299129, 299133, 299139, 299143
Country: HK	Department of Health Drug Office	Identifier(s): 41578, 41579
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-369514985, HR-H-730140520
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6989
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1070442, 1070443, 1070444, 1072697, 1072698, 1072699, 1072700, 1072701, 1072702, 1072703, 1089198, 1089199, 1089200
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 7819, 7820
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100315580, 100315605, 100315628
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W43810001, W43810002, W43810003, W43811001, W43811002, W43811003, W43811004, W43811005, W43812001, W43812002
Country: SG	Health Sciences Authority	Identifier(s): 09008P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 5643021, 5643022, 5643023
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699679775009, 8699679775016, 8699679775023
Country: US	FDA, National Drug Code	Identifier(s): 67684-2000, 67684-2001, 67684-3001
Country: ZA	Health Products Regulatory Authority	Identifier(s): 31/28/0550, 31/28/0551