| Product Information |
|
| Registration Number |
BR-446
|
| Generic Name |
Human Plasma Coagulation Factor VIII
|
| Brand Name |
Beriate
|
| Dosage Strength |
100 IU/mL (500 IU/5 mL)
|
| Dosage Form |
Powder for Intravenous Injection or Infusion
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Clear and colorless glass vial + diluent vial (5 mL) + transfer set + disposable filter spike (in box)
|
| Pharmacologic Category |
Plasma Fractions for Specific Use
|
| Manufacturer |
CSL Behring GmbH
|
| Country of Origin |
Germany
|
| Trader |
|
| Importer |
Zuellig Pharma Corporation
|
| Distributor |
Zuellig Pharma Corporation
|
| Application Type |
Renewal
|
| Issuance Date |
03 June 2020
|
| Expiry Date |
03 January 2025
|