| Product Information |
|
| Registration Number |
DRP-12331
|
| Generic Name |
Vinorelbine (as Tartrate)
|
| Brand Name |
Prorelbine
|
| Dosage Strength |
10 mg/ mL (50mg/5mL)
|
| Dosage Form |
Solution For Injection (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic Agent (Vinca alkaloid and analogue)
|
| Packaging |
2 ml Type I Clear Glass Vial Sealed with Gray Bromobutyl Rubber Stopper and Sky-Blue Aluminum Flip-Off Seal Cap x 1mL (Net content) (Box of l’s); 6 mL Type I Clear Glass Vial Sealed with Gray Bromobutyl Rubber Stopper and Olive Drab Aluminum Flip-Off Seal Cap x 5mL (Net content) (Box of l’s)
|
| Manufacturer |
Jiangsu Hansoh Pharmaceutical Co., Ltd.
|
| Country of Origin |
China
|
| Trader |
N/A
|
| Importer |
Ambicare Pharmaceuticals, Inc.
|
| Distributor |
Ambicare Pharmaceuticals, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
19 July 2022
|
| Expiry Date |
19 July 2027
|