| Product Information |
|
| Registration Number |
BR-838
|
| Generic Name |
Denosumab
|
| Brand Name |
Prolia
|
| Dosage Strength |
60 mg/ mL
|
| Dosage Form |
Solution For Injection (Sc)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
1 mL Type 1 prefilled glass syringe with a bromobutyl plunger-stopper and a staked-in needle with an elastomeric needle shield enclosed in a plastic rigid cover (Box of 1's)
|
| Pharmacologic Category |
-
|
| Manufacturer |
Amgen Manufacturing Limited
|
| Country of Origin |
United States of America
|
| Trader |
|
| Importer |
Zuellig Pharma Corporation
|
| Distributor |
Zuellig Pharma Corporation
|
| Application Type |
Initial
|
| Issuance Date |
05 October 2020
|
| Expiry Date |
22 December 2024
|