OMNIPAQUE

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

Active ingredients

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

1	Iohexol UNII 4419T9MX03 - IOHEXOL
	Iohexol is an effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.
	Read more about Iohexol

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
OMNIPAQUE Solution	MPI, EU: SmPC	Medicines and Medical Devices Safety Authority (NZ)

Medicine classification

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

ATC Group		Classification
V08AB02	Iohexol	V Various → V08 Contrast media → V08A X-ray contrast media, iodinated → V08AB Watersoluble, nephrotropic, low osmolar X-ray contrast media
Discover more medicines within V08AB02

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	541612040000503, 541612040000603, 541612040000703, 541612040000803, 541617040002303, 541617040002403
CA	Health Products and Food Branch	02172720, 02172739, 02172747, 02172755
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	1027-MEE-0615, 936-MEE-0415
EE	Ravimiamet	1005938, 1005961, 1005983, 1078972, 1078983, 1078994, 1079007, 1079018, 1079029, 1079041, 1079052, 1079063, 1079074, 1135246, 1135257, 1135279, 1135280, 1135291, 1135303, 1135325, 1135336, 1135347, 1173260, 1173282, 1173293, 1420434, 1420445, 1420456, 1420478, 1420489, 1420490, 1420513, 1420524, 1420546, 1420557, 1420568, 1420579
ES	Centro de información online de medicamentos de la AEMPS	62017, 62018, 62019
FI	Lääkealan turvallisuus- ja kehittämiskeskus	019066, 019088, 019099, 019112, 065870, 068528, 582221, 582353, 582452, 582627, 582635, 582650, 582692, 582809
FR	Base de données publique des médicaments	63688752, 65106581, 66892062, 67846776
GB	Medicines & Healthcare Products Regulatory Agency	236229, 326403, 326407, 91759, 91767, 91769, 91770, 91772, 91773, 91775, 91776, 91777, 91780, 91781
HK	Department of Health Drug Office	44111, 44112
HR	Agencija za lijekove i medicinske proizvode	HR-H-246368013, HR-H-813025640
LT	Valstybinė vaistų kontrolės tarnyba	1010762, 1010763, 1010764, 1010765, 1010766, 1010767, 1010768, 1010769, 1010770, 1010771, 1010772, 1010773, 1010774, 1010775, 1010776, 1026443, 1026444, 1026445, 1027265, 1027266, 1027267, 1027268, 1027269, 1027270, 1027271, 1027272, 1027273, 1027274, 1066968, 1066969, 1066970, 1066971, 1066972, 1066973, 1066974, 1066975, 1066976, 1066977, 1066978, 1066979, 1066980, 1071091, 1088455, 1089155
MT	Medicines Authority	MA023/00301, MA023/00302
NZ	Medicines and Medical Devices Safety Authority	3993, 3994, 3995
PL	Rejestru Produktów Leczniczych	100049492, 100049517, 100102789
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W07800004, W07804004, W07804005, W07804007, W07804009, W07804010, W07804011, W07804012, W07804013, W07804014, W07807004, W07807007, W07807009, W07807010, W07807011, W07807012, W07807013, W07807014, W07807015, W07807016
SG	Health Sciences Authority	05923P, 05924P
TN	Direction de la Pharmacie et du Médicament	2453012, 2453013, 2453014, 2453015, 2453021
TR	İlaç ve Tıbbi Cihaz Kurumu	8699688771443, 8699688771450, 8699688771542, 8699688771559, 8699688771603
US	FDA, National Drug Code	0407-1401, 0407-1411, 0407-1412, 0407-1413, 0407-1414, 0407-1415, 0407-1416
ZA	Health Products Regulatory Authority	35/28/0383, 35/28/0389, 35/28/0391, R/28/131, R/28/132, R/28/134, X/28/80, X/28/81