ELFABRIO
Active substance: pegunigalsidase alfa
INJECTION, SOLUTION, CONCENTRATE · PEGUNIGALSIDASE ALFA 5 mg/2.5mL
United StatesActive
Marketing holder: Chiesi USA, Inc.
Verified 2026-10-09 · openFDA NDC
Analogues in other countries- Source: openFDA NDC
- Countries with the substance registered: 2
Composition
- PEGUNIGALSIDASE ALFA · 5 mg/2.5mL
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| EU 1 |
|
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a1208d-f956-7566-a3ca-d9c84cc07691,01a1209a-bc60-7ea4-8b3c-3e033ea2ec5b;count=2 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 10122-165
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- INTRAVENOUS
Sources
- product · openFDA NDC · 10122-165 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 10122-165 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 10122-165 · Verified 2026-10-09 · open in source