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Predex - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Predex
Approved
STANDARD
Predex
Themis Medicare Limited
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
19453be9ba6fe3ea
Company
Themis Medicare Limited
Type
Standard
Approval Details
Approval Id
19453be9ba6fe3ea
Drug Approval Philippines Name
Predex
Product Name
Predex
Registration Number
DR-XY47784
Brand Name
Predex
Generic Name
Dexmedetomidine (as hydrochloride)
Dosage Form
Concentrate for Solution for Infusion (IV)
Dosage Strength
100 mcg/mL (200 mcg/2 mL)
Manufacturer
Themis Medicare Limited
Importer
Innogen Pharmaceuticals, Inc.
Distributor
Innogen Pharmaceuticals, Inc.
Company Detail Path
/organization/themis-medicare-limited
Issuance Date
08 March 2022
Expiry Date
08 March 2027
Pharmacologic Category
Hypnotic/Sedative
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
19453be9ba6fe3ea
Type
Standard
Back to Philippines FDA Approvals