| Product Information |
|
| Registration Number |
DRP-13532
|
| Generic Name |
Epirubicin Hydrochloride
|
| Brand Name |
Rubifon
|
| Dosage Strength |
2 mg/mL (10 mg/5 mL)
|
| Dosage Form |
Concentrate solution for
Injection (IV/Intravesical)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
6 mL-Capacity USP Type I Clear Glass Vial with Grey Chlorobutyl Rubber Stopper and Blue Aluminum Flip-Off Seal x 5 mL (net content) (Box of 1's)
|
| Manufacturer |
PT. Fonko International Pharmaceuticals
|
| Country of Origin |
Indonesia
|
| Trader |
N/A
|
| Importer |
Glorious Dexa Mandaya, Inc.
|
| Distributor |
N/A
|
| Application Type |
DRP-13532
|
| Issuance Date |
08 March 2023
|
| Expiry Date |
08 March 2028
|