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)
|
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)
|
Pharmacologic Category |
Porcine Pulmonary Surfactant
|
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
|