Replagal 1 mg/ml, concentraat voor oplossing voor intraveneuze infusie

{
  "form": "Concentraat voor oplossing voor infusie",
  "route": "Intraveneus gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/replagal-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Agalsidase Alfa",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp71067",
  "excipients": [
    "NATRIUMCHLORIDE",
    "NATRIUMDIWATERSTOFFOSFAAT 1-WATER (E 339)",
    "NATRIUMHYDROXIDE (E 524)",
    "POLYSORBAAT 20 (E 432)",
    "STIKSTOF (HEAD SPACE) (E 941)",
    "WATER VOOR INJECTIE"
  ],
  "substances": [
    "AGALSIDASE ALFA (RECOMBINANT) \"BSCP\""
  ],
  "leaflet_url": null,
  "authorised_at": "2001/08/03",
  "procedure_number": "EMEA/H/C/000369",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/01/189",
  "additional_monitoring": "N"
}