| Product Information |
|
| Registration Number |
BR-1048
|
| Generic Name |
Agalsidase Beta
|
| Brand Name |
Fabrazyme
|
| Dosage Strength |
35 mg
|
| Dosage Form |
Powder for Concentrate for Solution for
Infusion (IV)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
20 mL Type I glass vial with gray chlorobutyl stopper
and aluminum crimp seal (Box of 1's)
|
| Pharmacologic Category |
-
|
| Manufacturer |
Genzyme Ireland Limited
|
| Country of Origin |
Ireland
|
| Trader |
N/A
|
| Importer |
Sanofi-Aventis Philippines, Inc.
|
| Distributor |
N/A
|
| Application Type |
Renewal
|
| Issuance Date |
21 November 2023
|
| Expiry Date |
07 December 2028
|