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NL · NL · NL-5c858cec1dff

Ekterly 300 mg filmomhulde tabletten

ATC B06AC08

Last synced from CBG-MEB (Netherlands) on

Identification

ManufacturerKalvista Pharmaceuticals (Ireland) Limited
CountryNL (NL)
ATC codeB06AC08
Dispensing
ReimbursedNo
SourceCBG-MEB (Netherlands)
Last synced6/9/2026

Packs · 1

  • cbg_meb_id
    EU/1/25/1975

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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/ekterly-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Sebetralstat",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp133914",
  "excipients": [
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "COPOLYMEER VAN MACROGOL (25,0)-POLY(VINYL ALCOHOL) (75,0) (E 1209)",
    "CROSCARMELLOSE  NATRIUM  (E 468)",
    "GLYCEROL MONOCAPRYLOCAPRAAT, TYPE I",
    "GUAR GOM (E 412)",
    "HYPROMELLOSE (E 464)",
    "IJZEROXIDE GEEL (E 172)",
    "IJZEROXIDE ZWART (E 172)",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MALTODEXTRINE",
    "POLYVINYLALCOHOL (E 1203)",
    "POVIDON K 30 (E 1201)",
    "TALK (E 553b)",
    "TITAANDIOXIDE (E 171)",
    "TRIGLYCERIDEN MIDDELLANGE KETEN"
  ],
  "substances": [
    "SEBETRALSTAT"
  ],
  "leaflet_url": null,
  "authorised_at": "2025/09/17",
  "procedure_number": "EMEA/H/C/006211",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/25/1975",
  "additional_monitoring": "Y"
}

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