Ireland· IE-PA-EU/1/22/1652/001-002

Filsuvez

A birkenrinde product containing betulae cortex dry extract (5-10 : 1); extraction solvent: n-heptane 95% (w/w), registered in Ireland by Chiesi Farmaceutici S.p.A.. The same ATC class is registered in 10 of our 19 countries.

ATC D03AX13

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedFilsuvezATCD03AX13REGISTER NO.IE-PA-EU/1/22/1652/00…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Birkenrinde is registered in 10 of 19 countries.

Countries holding a registration under ATC D03AX13 (birkenrinde), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 7 of them publish a price we can compare per daily dose

Birkenrinde · ATC D03AX13

10 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
BETULAE CORTEX DRY EXTRACT (5-10 : 1); EXTRACTION SOLVENT: N-HEPTANE 95% (W/W)
Manufacturer
Chiesi Farmaceutici S.p.A.
Country
Ireland (IE)
ATC code
D03AX13
ATC class
Birkenrinde
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/22/1652/001-002

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/ec75d6d8-9c81-46d7-a84a-45e8b0cbb0c1
GET /v1/drugs/ec75d6d8-9c81-46d7-a84a-45e8b0cbb0c1?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "form": "Gel",
  "routes": null,
  "source": "hpra",
  "atc_all": [
    "D03AX",
    "D03AX13"
  ],
  "strength": null,
  "pa_number": "EU/1/22/1652/001-002",
  "substances": [
    "BETULAE CORTEX DRY EXTRACT (5-10 : 1); EXTRACTION SOLVENT: N-HEPTANE 95% (W/W)"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "21/06/2022",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about birkenrinde.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.