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IE · IE · IE-PA-EU/1/23/1737/001-002

Opfolda 65 mg hard capsules

ATC A16AX06

Last synced from HPRA (Ireland) on

Identification

ManufacturerAmicus Therapeutics Europe Limited
CountryIE (IE)
ATC codeA16AX06
Dispensing
ReimbursedNo
SourceHPRA (Ireland)
Last synced6/8/2026

Packs · 1

  • ie_pa_number
    EU/1/23/1737/001-002

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Raw payload (JSON)
{
  "form": "Capsule, hard",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "A16AX06"
  ],
  "strength": null,
  "pa_number": "EU/1/23/1737/001-002",
  "substances": [
    "Miglustat"
  ],
  "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "26/06/2023",
  "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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