| Product Information |
|
| Registration Number |
DR-XY41156
|
| Generic Name |
Poractant Alfa
|
| Brand Name |
Curosurf
|
| Dosage Strength |
80mg/mL
|
| Dosage Form |
Sterile Suspension (Intratracheal/Intrabronchial)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Porcine Pulmonary Surfactant
|
| Packaging |
3 mL net content in 5 mL-capacity EP Type I clear
and colorless glass vial with grey chlorobutyl rubber stopper and aluminum seal with plastic flip-off cap (Box of l’s); 1.5 mL net content in 5 mL-capacity EP Type I clear and colorless glass vial with grey chlorobutyl rubber stopper and aluminum seal with plastic flip-off cap (Box of 1’s)
|
| Manufacturer |
Chiesi Farmaceutici
|
| Country of Origin |
Italy
|
| Trader |
Hyphens Pharma Pte. Ltd.
|
| Importer |
Hyphens Pharma Philippines, Inc.
|
| Distributor |
Hyphens Pharma Philippines, Inc.
|
| Application Type |
Initial (from Monitored Release Extension)
|
| Issuance Date |
30 May 2022
|
| Expiry Date |
04 September 2025
|