Bendamustin Puren

Arzneimittel · European Medicines Agency · Deutschland

Was die Quelle veröffentlicht

Zulassungsinhaber: Eugia Pharma (Malta) Limited
Wirkstoffe: Bendamustine Hydrochloride
Verabreichungswege: Intravenous Use
Administrativer Status: listed-as-authorised

Namen, unter denen dieser Datensatz gefunden wird

Vollständige Quelldaten

de:ema:article57:dcbc03e1d6bd6b89be49

{
  "name": "Bendamustin Puren",
  "holder": "Eugia Pharma (Malta) Limited",
  "routes": [
    "Intravenous Use"
  ],
  "marketed": null,
  "useDomain": "unknown",
  "databaseDate": "2026-10-09",
  "sourceStatus": null,
  "supplyRegime": null,
  "listingStatus": "listed-as-authorised",
  "targetSpecies": [],
  "sourceRowCount": 1,
  "activeSubstances": [
    "Bendamustine Hydrochloride"
  ],
  "documentRevision": "90",
  "documentReference": "EMA/518502/2018",
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "de.ema.article57"
  },
  "patientEligibility": "not-assessed",
  "centrallyAuthorised": false,
  "targetSpeciesStatus": "not-reported",
  "activeSubstancesText": "Bendamustine Hydrochloride",
  "administrativeStatus": "unknown",
  "prescriptionCategory": "unknown",
  "prescriptionRequired": null,
  "authorisationTerritory": "Germany",
  "pharmacovigilanceContacts": [
    {
      "email": "eupvg@eugiapharma.com",
      "phone": "+ 356 22294000",
      "masterFileLocation": "Malta"
    }
  ]
}

EMA-Produktliste nach Artikel 57

Source: European Medicines Agency (EMA), Article 57 product data (EMA/518502/2018), based on data submitted by marketing-authorisation holders.

Abgerufen am: 8. November 2026
Lizenz: Bedingungen des Herausgebers
Quellen-ID: de.ema.article57

Amtliche Quelle

Was diese Quelle nicht belegt

Germany has no free, complete official bulk medicine database with PZNs: BfArM’s AMIce public search is interactive only, its § 31b reference database is supplied to commercial users on request, and the GKV-Spitzenverband and BfArM price lists are PDF-only for reasons of usage rights.
EMA’s Article 57 export names every medicinal product authorised in Germany (national, mutual-recognition and decentralised procedures) and every centrally authorised EU product, as submitted by marketing-authorisation holders; submissions can lag an authorisation change.
A record is one product name, active-substance text, route and marketing-authorisation holder. Strengths, forms, packs, PZNs, authorisation numbers and dates are not published, so rows EMA lists more than once for one such product are kept together with their count.
The export publishes no legal category (verschreibungspflichtig, apothekenpflichtig, freiverkäuflich), so the prescription classification stays unknown; listing is not proof of current authorisation, marketing, availability or reimbursement.
Active-substance names are the English xEVMPD names EMA publishes, not German INN spellings.
EMA’s legal notice permits commercial and non-commercial reproduction with acknowledgement of EMA as the source; its exception for third-party content leaves the status of holder-submitted text unconfirmed.

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GET /v1/drugs/record

curl -G "https://api.medifontis.com/v1/drugs/record" \
  -H "Authorization: Bearer $MEDIFONTIS_API_KEY" \
  --data-urlencode "country=de" \
  --data-urlencode "sourceId=de.ema.article57" \
  --data-urlencode "id=de:ema:article57:dcbc03e1d6bd6b89be49"