| Product Information |
|
| Registration Number |
BR-1045
|
| Generic Name |
Idursulfase
|
| Brand Name |
Elaprase
|
| Dosage Strength |
6 mg/3 mL (2 mg/mL)
|
| Dosage Form |
Concentrate for Solution for
Infusion (IV)
|
| Classification |
Prescription Drug (Rx)
|
| Packaging |
Type I clear and colorless glass vial (Box of 1's)
|
| Pharmacologic Category |
Enzymes
|
| Manufacturer |
Vetter Pharma-Fertigung GmbH & Co. KG
|
| Country of Origin |
Germany
|
| Trader |
|
| Importer |
Sanofi-Aventis Philippines, Inc.
|
| Distributor |
Sanofi-Aventis Philippines, Inc.
|
| Application Type |
Renewal
|
| Issuance Date |
20 March 2024
|
| Expiry Date |
09 December 2028
|