Predex
Brand Name: Predex
Generic Name: Dexmedetomidine (as hydrochloride)
Active
Registration Number
DR-XY47784
Dosage Form
Concentrate for Solution for Infusion (IV)
Issuance Date
March 8, 2022
Expiry Date
March 8, 2027
Product Information
Philippine FDA product specifications and classification details
Product Specifications
Dosage Strength100 mcg/mL (200 mcg/2 mL)
Packaging2 mL USP Type I amber colored ampoule with white colored ring in Polyvinyl Chloride (PVC) tray (Box of 1's)
Classification
C
Classification
Prescription Drug (RX)
P
Pharmacologic
Hypnotic/Sedative
A
Application
Monitored Release
Philippine FDA Classification
Active Ingredients (1)
Complete list of active ingredients in this pharmaceutical product.
Dexmedetomidine (as hydrochloride)Active
Monograph: Buccal Dexmedetomidine (Reconnect Labs)