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Folotyn

Active substance: pralatrexate

pralatrexate

Centralised EU authorisationActive

Marketing holder: Allos Therapeutics Ltd

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 6
  • Folotyn
    INJECTION · PRALATREXATE 20 mg/mL
    72893-003
    Acrotech Biopharma Inc
  • Folotyn
    INJECTION · PRALATREXATE 40 mg/2mL
    72893-005
    Acrotech Biopharma Inc
  • Pralatrexate
    INJECTION · PRALATREXATE 20 mg/mL
    65219-550
    Fresenius Kabi USA, LLC
  • Pralatrexate
    INJECTION · PRALATREXATE 20 mg/mL
    43598-342
    Dr.Reddy's Laboratories Inc.,
  • Pralatrexate
    INJECTION · PRALATREXATE 40 mg/2mL
    43598-343
    Dr.Reddy's Laboratories Inc.,
All products in this country (6)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-be1c-7d86-bef7-d630432f1770,01a1208e-af88-7593-9907-40568c8715d7,01a1208f-afe2-780d-9649-a5523a76848a,01a1208f-afe5-7cf5-a5b2-55526984f64d,01a12099-1a5d-7f40-b653-0817aed1a564;count=6 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002096
Registration status
Active
ATC code
L01BA05
Sources
  • product · EMA · EMEA/H/C/002096 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002096 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002096 · Verified 2026-10-09