GEMCITABINA SUN 10 MG/ML SOLUCION PARA PERFUSION , 1 bolsa de 160 ml

Medicine package · Agencia Española de Medicamentos y Productos Sanitarios · Spain

Registration number 80814
National code 710607

What the source publishes

Holder: Sun Pharmaceutical Industries (Europe) B.V.
Active ingredients: GEMCITABINA HIDROCLORURO
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:710607

{
  "form": null,
  "name": "GEMCITABINA SUN 10 MG/ML SOLUCION PARA PERFUSION , 1 bolsa de 160 ml",
  "holder": "Sun Pharmaceutical Industries (Europe) B.V.",
  "smpcUrl": "https://cima.aemps.es/cima/pdfs/ft/80814/FT_80814.pdf",
  "doseText": null,
  "marketed": true,
  "documents": [
    {
      "url": "https://cima.aemps.es/cima/pdfs/ft/80814/FT_80814.pdf",
      "type": 1,
      "htmlUrl": null,
      "modifiedAtEpochMs": null
    },
    {
      "url": "https://cima.aemps.es/cima/pdfs/p/80814/P_80814.pdf",
      "type": 2,
      "htmlUrl": null,
      "modifiedAtEpochMs": null
    }
  ],
  "useDomain": "human",
  "leafletUrl": "https://cima.aemps.es/cima/pdfs/p/80814/P_80814.pdf",
  "nationalCode": "710607",
  "supplyRegime": "Uso Hospitalario",
  "regionalRules": "not-collected",
  "supplyProblem": false,
  "targetSpecies": [],
  "nonSubstitutable": {
    "id": 0,
    "nombre": "N/A"
  },
  "activeIngredients": [
    {
      "id": 7314,
      "orden": 1,
      "codigo": "7314CH",
      "nombre": "GEMCITABINA HIDROCLORURO",
      "unidad": "mg",
      "cantidad": "11,384"
    }
  ],
  "useDomainEvidence": {
    "basis": "publisher-dataset-scope",
    "field": "sourceId",
    "value": "es.aemps.cima",
    "version": 1,
    "sourceId": "es.aemps.cima"
  },
  "patientEligibility": "not-assessed",
  "registrationNumber": "80814",
  "targetSpeciesStatus": "not-applicable",
  "administrationRoutes": null,
  "administrativeStatus": "authorised",
  "prescriptionCategory": "prescription-or-restricted",
  "prescriptionRequired": true,
  "activeIngredientsText": "GEMCITABINA HIDROCLORURO",
  "registrationListedInCima": true,
  "administrativeStatusScope": "presentation",
  "administrativeDatesEpochMs": {
    "aut": 1494922810000
  }
}

CIMA medicines and packages

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es

Retrieved: November 12, 2026
Licence: Publisher terms
Source id: es.aemps.cima

Official source

What this source does not establish

Complete unfiltered human-medicine registrations and presentations currently exposed by CIMA, not a historical archive of all Spanish authorisations.
Two identical full passes detect observed drift but CIMA supplies no point-in-time snapshot guarantee.
Authorisation, marketing, prescription requirement and patient/prescriber eligibility are separate facts.
Autonomous-community reimbursement, dispensing pathways, treatment plans and patient eligibility are not collected.
Official document URLs and their supplied modification dates only; no document content or images are redistributed.
REST reuse relies on the AEMPS open-data listing and website notice, not a Creative Commons licence or the Nomenclátor bulk terms.

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