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IE · IE · IE-PA-EU/01/13/878/001

Defitelio 80 mg/mL concentrate for solution for infusion

ATC B01AX01

Last synced from HPRA (Ireland) on

Identification

ManufacturerGentium S.p.A.
CountryIE (IE)
ATC codeB01AX01
Dispensing
ReimbursedNo
SourceHPRA (Ireland)
Last synced6/8/2026

Packs · 1

  • ie_pa_number
    EU/01/13/878/001

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Raw payload (JSON)
{
  "form": "Concentrate for solution for infusion",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "B01AX",
    "B01AX01"
  ],
  "strength": null,
  "pa_number": "EU/01/13/878/001",
  "substances": [
    "Defibrotide"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "18/10/2013",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

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