| Product Information |
|
| Registration Number |
BRP-100-13
|
| Generic Name |
Epoetin Alfa
|
| Brand Name |
Gotein
|
| Dosage Strength |
4000 IU / mL
|
| Dosage Form |
Solution for Injection (IV/SC)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antianemic Preparations
|
| Packaging |
1 mL Type I pre-filled glass syringe with chlorobutyl plunger stopper and stainless-steel needle with a polyisoprene needle shield and sealed in blister / (Box of 1's)
|
| Manufacturer |
Shenyang Sunshine Pharmaceutical Co., Ltd.
|
| Country of Origin |
China
|
| Trader |
|
| Importer |
AMB HK Enterprises Inc.
|
| Distributor |
Applied Pharmaceutical Distribution Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
20 August 2024
|
| Expiry Date |
14 December 2026
|