| Product Information |
|
| Registration Number |
DRP-14128
|
| Generic Name |
Gadobutrol
|
| Brand Name |
Gadovision
|
| Dosage Strength |
1 mmol/mL (604.72 mg/mL)
|
| Dosage Form |
Solution for Injection
(I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Paramagnetic contrast media
|
| Packaging |
15 mL (net content) in 20 mL-capacity Pre-filled syringe consisting of USP Type I borosilicate glass. and 20 mm butyl rubber stopper (Box of 1's)
|
| Manufacturer |
Dongkook Pharmaceutical Co., Ltd.
|
| Country of Origin |
Korea
|
| Trader |
|
| Importer |
JLT Pharma Inc.
|
| Distributor |
JLT Pharma Inc.
|
| Application Type |
Initial
|
| Issuance Date |
22 December 2023
|
| Expiry Date |
23 June 2028
|