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NL · NL · NL-18f06a9876c7

Opfolda 65 mg harde capsules

ATC A16AX06

Last synced from CBG-MEB (Netherlands) on

Identification

ManufacturerAmicus Therapeutics Europe Limited
CountryNL (NL)
ATC codeA16AX06
Dispensing
ReimbursedNo
SourceCBG-MEB (Netherlands)
Last synced6/9/2026

Packs · 1

  • cbg_meb_id
    EU/1/23/1737

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Raw payload (JSON)
{
  "form": "Capsule, hard",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/opfolda-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Miglustat",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp129215",
  "excipients": [
    "AMMONIA (E 527)",
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "GELATINE (E 441)",
    "IJZEROXIDE ZWART (E 172)",
    "IJZEROXIDE ZWART (E 172)",
    "KALIUMHYDROXIDE (E 525)",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MAÏSZETMEEL, GEPREGELATINEERD",
    "PROPYLEENGLYCOL (E 1520)",
    "SCHELLAK (E 904)",
    "SILICIUMDIOXIDE (E 551)",
    "SUCRALOSE (E 955)",
    "TITAANDIOXIDE (E 171)",
    "ZWARTE INKT"
  ],
  "substances": [
    "MIGLUSTAT"
  ],
  "leaflet_url": null,
  "authorised_at": "2023/06/26",
  "procedure_number": "EMEA/H/C/005695",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/23/1737",
  "additional_monitoring": "N"
}

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