Orkambi 100 mg/125 mg, filmomhulde tablet

{
  "form": "Filmomhulde tablet",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/orkambi-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Ivacaftor and lumacaftor",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp120817",
  "excipients": [
    "AMMONIA (E 527)",
    "BRILJANTBLAUW FCF ALUMINIUMLAK (E133)",
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "CROSCARMELLOSE  NATRIUM  (E 468)",
    "HYPROMELLOSEACETAATSUCCINAAT",
    "IJZEROXIDE ZWART (E 172)",
    "INDIGOKARMIJN ALUMINIUMLAK (E 132)",
    "KARMIJN (E120)",
    "MACROGOL 3350",
    "MAGNESIUMSTEARAAT (E 470b)",
    "NATRIUMLAURILSULFAAT",
    "POLYVINYLALCOHOL (E 1203)",
    "POVIDON K 30 (E 1201)",
    "PROPYLEENGLYCOL (E 1520)",
    "SCHELLAK (E 904)",
    "TALK (E 553b)",
    "TITAANDIOXIDE (E 171)",
    "ZWARTE INKT"
  ],
  "substances": [
    "IVACAFTOR",
    "LUMACAFTOR"
  ],
  "leaflet_url": null,
  "authorised_at": "2018/01/08",
  "procedure_number": "EMEA/H/C/003954",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/15/1059",
  "additional_monitoring": "N"
}