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Saphnelo

Active substance: Anifrolumab

anifrolumab

Centralised EU authorisationActive

Marketing holder: AstraZeneca AB

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 2
  • SAPHNELO
    INJECTION, SOLUTION · ANIFROLUMAB 300 mg/2mL
    0310-3040
    AstraZeneca Pharmaceuticals LP
  • SAPHNELO
    INJECTION, SOLUTION · ANIFROLUMAB 120 mg/.8mL
    0310-3080
    AstraZeneca Pharmaceuticals LP
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12094-2aad-77aa-9859-cefab9447df1,01a1209d-d97a-7010-ba58-a3866d11c639;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004975
Registration status
Active
ATC code
L04AG11
Sources
  • product · EMA · EMEA/H/C/004975 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004975 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004975 · Verified 2026-10-09