| Product Information |
BR-1047_PI_01.pdf
|
| Registration Number |
BR-1047
|
| Generic Name |
Agalsidase Beta
|
| Brand Name |
Fabrazyme
|
| Dosage Strength |
5 mg
|
| Dosage Form |
Powder for Concentrate for Solution for Infusion (IV)
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
Enzyme
|
| Packaging |
5 mL capacity Type I clear and colorless glass vial with gray chlorobutyl rubber stopper and aluminum crimp seal (Box of 1's).
|
| Manufacturer |
Genzyme Ireland Limited
|
| Country of Origin |
Ireland
|
| Trader |
|
| Importer |
Sanofi-Aventis Philippines, Inc..
|
| Distributor |
Sanofi-Aventis Philippines, Inc..
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
13 September 2024
|
| Expiry Date |
13 September 2029
|