BERIATE 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE Y PARA PERFUSION , 1 vial + 1 vial de disolvente

Medicine package 路 Agencia Espa帽ola de Medicamentos y Productos Sanitarios 路 Spain

  • Registration number 63023
  • National code 875021

What the source publishes

Holder
Csl Behring Gmbh
Active ingredients
FACTOR VIII
Administrative status
authorised
Supply regime
Uso Hospitalario
Prescription
Prescription or restricted

Publisher documents

Names this record is found by

Complete source data
es:cima:packages:875021
{
  "form": null,
  "name": "BERIATE 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE Y PARA PERFUSION , 1 vial + 1 vial de disolvente",
  "holder": "Csl Behring Gmbh",
  "smpcUrl": "https://cima.aemps.es/cima/pdfs/ft/63023/FT_63023.pdf",
  "doseText": null,
  "marketed": true,
  "documents": [
    {
      "url": "https://cima.aemps.es/cima/pdfs/ft/63023/FT_63023.pdf",
      "type": 1,
      "htmlUrl": null,
      "modifiedAtEpochMs": null
    },
    {
      "url": "https://cima.aemps.es/cima/pdfs/p/63023/P_63023.pdf",
      "type": 2,
      "htmlUrl": null,
      "modifiedAtEpochMs": null
    }
  ],
  "useDomain": "human",
  "leafletUrl": "https://cima.aemps.es/cima/pdfs/p/63023/P_63023.pdf",
  "nationalCode": "875021",
  "supplyRegime": "Uso Hospitalario",
  "regionalRules": "not-collected",
  "supplyProblem": false,
  "targetSpecies": [],
  "nonSubstitutable": {
    "id": 1,
    "nombre": "Biol贸gicos"
  },
  "activeIngredients": [
    {
      "id": 917,
      "orden": 1,
      "codigo": "917A",
      "nombre": "FACTOR VIII",
      "unidad": "UI",
      "cantidad": "500"
    }
  ],
  "useDomainEvidence": {
    "basis": "publisher-dataset-scope",
    "field": "sourceId",
    "value": "es.aemps.cima",
    "version": 1,
    "sourceId": "es.aemps.cima"
  },
  "patientEligibility": "not-assessed",
  "registrationNumber": "63023",
  "targetSpeciesStatus": "not-applicable",
  "administrationRoutes": null,
  "administrativeStatus": "authorised",
  "prescriptionCategory": "prescription-or-restricted",
  "prescriptionRequired": true,
  "activeIngredientsText": "FACTOR VIII",
  "registrationListedInCima": true,
  "administrativeStatusScope": "presentation",
  "administrativeDatesEpochMs": {
    "aut": 1000159200000
  }
}

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