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NL · NL · NL-f91f3f4e6bf9

Opsumit 10 mg, filmomhulde tablet

ATC C02KX04

Last synced from CBG-MEB (Netherlands) on

Identification

ManufacturerJanssen-Cilag International NV
CountryNL (NL)
ATC codeC02KX04
Dispensing
ReimbursedNo
SourceCBG-MEB (Netherlands)
Last synced6/9/2026

Packs · 1

  • cbg_meb_id
    EU/1/13/893

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Raw payload (JSON)
{
  "form": "Filmomhulde tablet",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/opsumit-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Macitentan",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp112884",
  "excipients": [
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "LACTOSE 1-WATER",
    "LECITHINE, SOYA (E 322)",
    "MAGNESIUMSTEARAAT (E 470b)",
    "NATRIUMZETMEELGLYCOLAAT",
    "POLYSORBAAT 80 (E 433)",
    "POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203)",
    "POVIDON (E 1201)",
    "TALK (E 553b)",
    "TITAANDIOXIDE (E 171)",
    "XANTHAANGOM (E 415)"
  ],
  "substances": [
    "MACITENTAN"
  ],
  "leaflet_url": null,
  "authorised_at": "2013/12/20",
  "procedure_number": "EMEA/H/C/002697",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/13/893",
  "additional_monitoring": "N"
}

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