| Product Information |
|
| Registration Number |
DR-XY48714
|
| Generic Name |
Gadoteric Acid
|
| Brand Name |
Clariscan
|
| Dosage Strength |
0.5 mmol/mL (equivalent to 279.32 mg/mL)
|
| Dosage Form |
Solution for Injection (I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
USP Type I Clear glass vial closed with chlorobutyl and bromobutyl rubber stopper and aluminum cap coloured plastic top x 10 mL and 20 mL (Box of 10's).
|
| Manufacturer |
GE Healthcare AS - Oslo Plant
|
| Country of Origin |
Norway
|
| Trader |
N/A
|
| Importer |
A. Menarini Philippines, Inc.
|
| Distributor |
A. Menarini Philippines, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
28 April 2023
|
| Expiry Date |
28 April 2028
|