SARCLISA 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION, 1 vial de 25 ml

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

  • Registration number 1201435001IP
  • National code 764310

What the source publishes

Holder
Sanofi Winthrop Industrie
Active ingredients
ISATUXIMAB
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:764310
{
  "form": null,
  "name": "SARCLISA 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION, 1 vial de 25 ml",
  "holder": "Sanofi Winthrop Industrie",
  "smpcUrl": "https://cima.aemps.es/cima/pdfs/ft/1201435001IP/FT_1201435001IP.pdf",
  "doseText": null,
  "marketed": false,
  "documents": [
    {
      "url": "https://cima.aemps.es/cima/pdfs/ft/1201435001IP/FT_1201435001IP.pdf",
      "type": 1,
      "htmlUrl": null,
      "modifiedAtEpochMs": null
    },
    {
      "url": "https://cima.aemps.es/cima/pdfs/p/1201435001IP/P_1201435001IP.pdf",
      "type": 2,
      "htmlUrl": null,
      "modifiedAtEpochMs": null
    },
    {
      "url": "https://cima.aemps.es/cima/pdfs/ipe/1201435001IP/IPE_1201435001IP.pdf",
      "type": 3,
      "htmlUrl": null,
      "modifiedAtEpochMs": null
    }
  ],
  "useDomain": "human",
  "leafletUrl": "https://cima.aemps.es/cima/pdfs/p/1201435001IP/P_1201435001IP.pdf",
  "nationalCode": "764310",
  "supplyRegime": "Uso Hospitalario",
  "regionalRules": "not-collected",
  "supplyProblem": false,
  "targetSpecies": [],
  "nonSubstitutable": {
    "id": 1,
    "nombre": "Biol贸gicos"
  },
  "activeIngredients": [
    {
      "id": 9624,
      "orden": 1,
      "codigo": "9624A",
      "nombre": "ISATUXIMAB",
      "unidad": "mg",
      "cantidad": "20"
    }
  ],
  "useDomainEvidence": {
    "basis": "publisher-dataset-scope",
    "field": "sourceId",
    "value": "es.aemps.cima",
    "version": 1,
    "sourceId": "es.aemps.cima"
  },
  "patientEligibility": "not-assessed",
  "registrationNumber": "1201435001IP",
  "targetSpeciesStatus": "not-applicable",
  "administrationRoutes": null,
  "administrativeStatus": "authorised",
  "prescriptionCategory": "prescription-or-restricted",
  "prescriptionRequired": true,
  "activeIngredientsText": "ISATUXIMAB",
  "registrationListedInCima": true,
  "administrativeStatusScope": "presentation",
  "administrativeDatesEpochMs": {
    "aut": 1707838500000
  }
}

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