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ANDEXXA

Active substance: andexanet alfa

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · ANDEXANET ALFA 200 mg/20mL

United StatesActive

Marketing holder: AstraZeneca Pharmaceuticals LP

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 1
  • Ondexxya
    andexanet alfa
    EMEA/H/C/004108
    AstraZeneca AB
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12092-4377-7a73-9cf2-57dc3ce755cb;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
0310-3200
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 0310-3200 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 0310-3200 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 0310-3200 · Verified 2026-10-09 · open in source