Filsuvez

Medicine · European Medicines Agency · Germany

What the source publishes

Holder: Chiesi Farmaceutici S.P.A.
Active ingredients: Dry Extract Refined From Birch Bark, Equivalent To 0.5-1.0 G Birch Bark, Including 84-95 Mg Triterpenes Calculated As The Sum Of Betulin, Betulinic Acid, Erythrodiol, Lupeol And Oleanolic Acid, Extraction Solvent: N-Heptane
Routes: Cutaneous Use
Administrative status: listed-as-authorised

Names this record is found by

Filsuvez
Dry Extract Refined From Birch Bark, Equivalent To 0.5-1.0 G Birch Bark, Including 84-95 Mg Triterpenes Calculated As The Sum Of Betulin, Betulinic Acid, Erythrodiol, Lupeol And Oleanolic Acid, Extraction Solvent: N-Heptane

Complete source data

de:ema:article57:a254d2b8d9ffbae8bedd

{
  "name": "Filsuvez",
  "holder": "Chiesi Farmaceutici S.P.A.",
  "routes": [
    "Cutaneous Use"
  ],
  "marketed": null,
  "useDomain": "unknown",
  "databaseDate": "2026-10-09",
  "sourceStatus": null,
  "supplyRegime": null,
  "listingStatus": "listed-as-authorised",
  "targetSpecies": [],
  "sourceRowCount": 1,
  "activeSubstances": [
    "Dry Extract Refined From Birch Bark, Equivalent To 0.5-1.0 G Birch Bark, Including 84-95 Mg Triterpenes Calculated As The Sum Of Betulin, Betulinic Acid, Erythrodiol, Lupeol And Oleanolic Acid, Extraction Solvent: N-Heptane"
  ],
  "documentRevision": "90",
  "documentReference": "EMA/518502/2018",
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "de.ema.article57"
  },
  "patientEligibility": "not-assessed",
  "centrallyAuthorised": true,
  "targetSpeciesStatus": "not-reported",
  "activeSubstancesText": "Dry Extract Refined From Birch Bark, Equivalent To 0.5-1.0 G Birch Bark, Including 84-95 Mg Triterpenes Calculated As The Sum Of Betulin, Betulinic Acid, Erythrodiol, Lupeol And Oleanolic Acid, Extraction Solvent: N-Heptane",
  "administrativeStatus": "unknown",
  "prescriptionCategory": "unknown",
  "prescriptionRequired": null,
  "authorisationTerritory": "European Union",
  "pharmacovigilanceContacts": [
    {
      "email": "pharmacovigilance-enquires@chiesi.com",
      "phone": "+39 0521 2791",
      "masterFileLocation": "Italy"
    }
  ]
}

EMA Article 57 product list

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

Retrieved: November 8, 2026
Licence: Publisher terms
Source id: de.ema.article57

Official source

What this source does not establish

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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