| Product Information |
|
| Registration Number |
DR-XY48148
|
| Generic Name |
Gadoteric Acid
|
| Brand Name |
Cyclolux
|
| Dosage Strength |
0.5 mmol/mL (equivalent to 279.32 mg/mL)
|
| Dosage Form |
Solution
for Injection (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Paramagnetic Contrast Media
|
| Packaging |
Type II Clear Glass Vial Sealed with Gray Bromobutyl
Rubber Stopper and Yellow Aluminum PP Flip-Off Cap x 10 mL, 15 mL and 20 mL (Box of l’s)
|
| Manufacturer |
Sanochemia Pharmazeutika GmbH
|
| Country of Origin |
Austria
|
| Trader |
|
| Importer |
Sankem Healthcare, Inc.
|
| Distributor |
|
| Application Type |
Initial
|
| Issuance Date |
30 June 2022
|
| Expiry Date |
30 June 2027
|