| Product Information |
|
| Registration Number |
DR-XY48646
|
| Generic Name |
Docetaxel
|
| Brand Name |
Brexel 80
|
| Dosage Strength |
10 mg/mL (80 mg/ 8 mL)
|
| Dosage Form |
Solution for Injection for I.V. Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
USP Type I clear glass vial with Grey Bromobutyl rubber stopper and Aluminum cap with plastic seal flip off x 8. mL (Box of 1's).
|
| Manufacturer |
PT. Global Onkolab Farma
|
| Country of Origin |
Indonesia
|
| Trader |
Kalbe International Pte, Ltd.
|
| Importer |
Globo Asiatico Enterprises, Inc.
|
| Distributor |
Globo Asiatico Enterprises, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
09 March 2023
|
| Expiry Date |
09 March 2028
|