PACLITAXEL KABI 6 mg/ml, solution à diluer pour perfusion — 1 flacon(s) en verre de 5 ml

Medicine package · Base de données publique des médicaments (BDPM), ANSM, HAS et Assurance Maladie · France

CIP13 3400957504151
CIP7 5750415
CIS 61174122

What the source publishes

Holder: FRESENIUS KABI FRANCE
Active ingredients: PACLITAXEL
Form: solution à diluer pour perfusion
Package: 1 flacon(s) en verre de 5 ml
Routes: intraveineuse
Administrative status: authorised
Supply regime: médicament nécessitant une surveillance particulière pendant le traitement ; prescription réservée aux spécialistes et services ONCOLOGIE MEDICALE ; prescription réservée aux spécialistes et services HEMATOLOGIE ; prescription hospitalière ; liste I ; prescription réservée aux médecins compétents en CANCEROLOGIE
Marketing status: Déclaration d'arrêt de commercialisation
Authorised on: 2009-04-15
Prescription: Prescription or restricted

Names this record is found by

Complete source data

fr:ansm:packages:3400957504151

{
  "cis": "61174122",
  "cip7": "5750415",
  "form": "solution à diluer pour perfusion",
  "name": "PACLITAXEL KABI 6 mg/ml, solution à diluer pour perfusion — 1 flacon(s) en verre de 5 ml",
  "cip13": "3400957504151",
  "holder": "FRESENIUS KABI FRANCE",
  "routes": [
    "intraveineuse"
  ],
  "holders": [
    "FRESENIUS KABI FRANCE"
  ],
  "currency": "EUR",
  "marketed": false,
  "bdmStatus": null,
  "useDomain": "unknown",
  "publicPrice": null,
  "authorisedOn": "2009-04-15",
  "compositions": [
    {
      "name": "PACLITAXEL",
      "nature": "SA",
      "strength": "6 mg",
      "linkageNumber": "1",
      "substanceCode": "20030",
      "dosageReference": "1 ml de solution à diluer pour perfusion",
      "pharmaceuticalElement": "solution"
    }
  ],
  "sourceStatus": "Présentation active",
  "supplyRegime": "médicament nécessitant une surveillance particulière pendant le traitement ; prescription réservée aux spécialistes et services ONCOLOGIE MEDICALE ; prescription réservée aux spécialistes et services HEMATOLOGIE ; prescription hospitalière ; liste I ; prescription réservée aux médecins compétents en CANCEROLOGIE",
  "dispensingFee": null,
  "medicinePrice": null,
  "regionalRules": "not-collected",
  "targetSpecies": [],
  "specialityName": "PACLITAXEL KABI 6 mg/ml, solution à diluer pour perfusion",
  "marketingStatus": "Déclaration d'arrêt de commercialisation",
  "publicationDates": {
    "CIS_bdpm": "2026-11-03",
    "CIS_CIP_bdpm": "2026-11-09",
    "CIS_CPD_bdpm": "2026-11-03",
    "CIS_COMPO_bdpm": "2026-11-03"
  },
  "specialityListed": true,
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "fr.ansm.bdpm"
  },
  "collectiveApproval": "non",
  "packageDescription": "1 flacon(s) en verre de 5 ml",
  "patientEligibility": "not-assessed",
  "reimbursementRates": [],
  "marketingDeclaredOn": "2026-03-31",
  "targetSpeciesStatus": "not-reported",
  "additionalMonitoring": false,
  "administrativeStatus": "authorised",
  "prescriptionCategory": "prescription-or-restricted",
  "activeIngredientNames": [
    "PACLITAXEL"
  ],
  "authorisationProcedure": "Procédure décentralisée",
  "prescriptionConditions": [
    "médicament nécessitant une surveillance particulière pendant le traitement",
    "prescription réservée aux spécialistes et services ONCOLOGIE MEDICALE",
    "prescription réservée aux spécialistes et services HEMATOLOGIE",
    "prescription hospitalière",
    "liste I",
    "prescription réservée aux médecins compétents en CANCEROLOGIE"
  ],
  "reimbursementIndications": null,
  "authorisationSourceStatus": "Autorisation active",
  "europeanAuthorisationNumber": null,
  "presentationAdministrativeStatus": "authorised"
}

Public medicines database (BDPM)

Source : Base de données publique des médicaments (BDPM), ANSM, HAS et Assurance Maladie — dates de mise à jour dans publicationDates ; https://base-donnees-publique.medicaments.gouv.fr

Retrieved: November 9, 2026
Licence: Licence Ouverte 1.0
Source id: fr.ansm.bdpm

Official source

What this source does not establish

Complete BDPM export, not a history of every French authorisation: the help page describes currently marketed medicines and those discontinued within five years, while the reviewed v4/v5 file specifications still say two years.
CIS identifies the specialty, CIP13 and CIP7 its presentation. All specialties remain searchable; prescriptions use named CIP13 presentations, and the four current presentations without a matching specialty are flagged, never matched by name or given invented parent data.
CIS_CPD publishes explicit dispensing conditions, not an OTC flag: list I, list II, narcotics and explicit prescribing or dispensing restrictions are prescription-or-restricted; absence of a condition stays unknown. No patient eligibility is assessed.
The effective pack administrative status preserves explicit licence suspension, withdrawal or cancellation over an active presentation. An archived or missing parent licence cannot establish authorisation; an explicitly cancelled presentation remains cancelled. Marketing declarations do not establish pharmacy stock.
The headerless files have the same strict positional schemas in the reviewed v4/v5 specifications. CIS, COMPO and CPD are Windows-1252, CIP is UTF-8; therapeutic fractions are FT in the export but ST in the specification, and three CPD CR-only blank lines are counted without dropping any condition.
The linked October 2011 Licence Ouverte v1.0 permits commercial redistribution and derived information with source and update-date attribution. BDPM’s download terms also require preservation of meaning, freshness checks and no suggestion of ANSM/HAS/Assurance Maladie endorsement.
SmPCs and patient leaflets are not in these bulk files: no document contents or guessed document URLs are collected. Safety information, shortages, HAS assessments and generic-group overlays are not collected.

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