ROMVIMZA 14 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/romvimza-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Other protein kinase inhibitors",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp133805",
  "excipients": [
    "CROSPOVIDON (E 1202)",
    "GELATINE (E 441)",
    "IJZEROXIDE ZWART (E 172)",
    "KALIUMHYDROXIDE (E 525)",
    "LACTOSE 1-WATER",
    "MAGNESIUMSTEARAAT (E 470b)",
    "PROPYLEENGLYCOL (E 1520)",
    "SCHELLAK (E 904)",
    "TITAANDIOXIDE (E 171)",
    "ZONNEGEEL FCF (E 110)",
    "ZWARTE INKT"
  ],
  "substances": [
    "VIMSELTINIB 2-WATER"
  ],
  "leaflet_url": null,
  "authorised_at": "2025/09/17",
  "procedure_number": "EMEA/H/C/006363",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/25/1968",
  "additional_monitoring": "Y"
}