This brand name is authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, Hong Kong SAR China, Ireland, Japan, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.
The drug PRIMOVIST contains one active pharmaceutical ingredient (API):
1
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UNII
HOY74VZE0M - GADOXETATE DISODIUM
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Gadoxetic acid is a paramagnetic contrast agent for magnetic resonance imaging. The contrast-enhancing effect is mediated by gadoxetate (Gd EOB DTPA), an ionic complex consisting of gadolinium (III) and the ligand ethoxybenzyl-diethylenetriamine-pentaacetic acid (EOB-DTPA). |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| PRIMOVIST Solution for injection | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| V08CA10 | Gadoxetic 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 | 538912030009902 |
| CA | Health Products and Food Branch | 02340666 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 29543-12-10 |
| EE | Ravimiamet | 1152739, 1152740, 1152751, 1152762, 1152773, 1152784, 1152795, 1152807, 1152818 |
| ES | Centro de información online de medicamentos de la AEMPS | 66648 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 018605 |
| GB | Medicines & Healthcare Products Regulatory Agency | 91681 |
| HK | Department of Health Drug Office | 54116 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-392143167 |
| JP | 医薬品医療機器総合機構 | 7290415G1020, 7290415G2027 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1016494, 1016495, 1016496, 1017860, 1017861, 1017862, 1017863, 1017864, 1017865 |
| MT | Medicines Authority | MA1354/00301 |
| NZ | Medicines and Medical Devices Safety Authority | 15065 |
| PL | Rejestru Produktów Leczniczych | 100131176 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W63890001, W63890002, W63890003, W63890004, W63890005, W63890006, W63890007, W63890008, W63890009, W63890010, W63890011, W63890012, W63890013, W63890014, W63890015 |
| SG | Health Sciences Authority | 13308P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699546959341 |
| ZA | Health Products Regulatory Authority | A40/28/0001, A40/28/0003 |
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