This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug DOTAREM contains one active pharmaceutical ingredient (API):
1
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UNII
L0ND3981AG - GADOTERATE MEGLUMINE
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Gadoteric acid has paramagnetic properties allowing MRI contrast enhancement. It has no specific pharmacodynamic activity and is biologically very inert. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| DOTAREM Solution for injection | MPI, EU: SmPC | Medicines and Medical Devices Safety Authority (NZ) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| V08CA02 | Gadoteric acid | V Various → V08 Contrast media → V08C Magnetic resonance imaging contrast media → V08CA Paramagnetic contrast media |
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 | 511000203154418, 511000204150416, 511000206153412, 511000209152417, 511021020006503, 511021020006603, 511021020006703 |
| CA | Health Products and Food Branch | 02459329 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 29864-06-11 |
| EE | Ravimiamet | 1619771, 1619782, 1619793, 1619805, 1619816, 1619861, 1619872, 1619894, 1619906, 1619917, 1826681, 1826692, 1826704 |
| ES | Centro de información online de medicamentos de la AEMPS | 62165, 67489 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 001829, 003867, 009414, 062422, 062513, 119908, 389541, 402612, 572131, 572263, 572339 |
| FR | Base de données publique des médicaments | 63078350, 69244971 |
| GB | Medicines & Healthcare Products Regulatory Agency | 299113, 299119, 299125, 299129, 299133, 299139, 299143 |
| HK | Department of Health Drug Office | 41578, 41579 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-369514985, HR-H-730140520 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 6989 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1070442, 1070443, 1070444, 1072697, 1072698, 1072699, 1072700, 1072701, 1072702, 1072703, 1089198, 1089199, 1089200 |
| NZ | Medicines and Medical Devices Safety Authority | 7819, 7820 |
| PL | Rejestru Produktów Leczniczych | 100315580, 100315605, 100315628 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W43810001, W43810002, W43810003, W43811001, W43811002, W43811003, W43811004, W43811005, W43812001, W43812002 |
| SG | Health Sciences Authority | 09008P |
| TN | Direction de la Pharmacie et du Médicament | 5643021, 5643022, 5643023 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699679775009, 8699679775016, 8699679775023 |
| US | FDA, National Drug Code | 67684-2000, 67684-2001, 67684-3001 |
| ZA | Health Products Regulatory Authority | 31/28/0550, 31/28/0551 |
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