Orfadin 10 mg, harde capsules

{
  "form": "Capsule, hard",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/orfadin-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Nitisinone",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp71864",
  "excipients": [
    "AMMONIA (E 527)",
    "GELATINE (E 441)",
    "IJZEROXIDE ZWART (E 172)",
    "MAÏSZETMEEL, GEPREGELATINEERD",
    "PROPYLEENGLYCOL (E 1520)",
    "SCHELLAK GLAZE, GEDEELTELIJK VERESTERD",
    "TITAANDIOXIDE (E 171)",
    "ZWARTE INKT"
  ],
  "substances": [
    "NITISINON"
  ],
  "leaflet_url": null,
  "authorised_at": "2005/02/21",
  "procedure_number": "EMEA/H/C/000555",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/04/303",
  "additional_monitoring": "N"
}