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Ireland· IE-PA-EU/1/20/1446/001

HEPCLUDEX 2 mg powder for solution for injection

A bulevirtide product containing bulevirtide, registered in Ireland by Gilead Sciences Ireland UC. The same ATC class is registered in 14 of our 19 countries.

ATC J05AX28

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedHEPCLUDEX 2 mg powder for solution fo…ATCJ05AX28REGISTER NO.IE-PA-EU/1/20/1446/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Bulevirtide is registered in 14 of 19 countries.

Countries holding a registration under ATC J05AX28 (bulevirtide), each read from that country’s own register.

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

Bulevirtide · ATC J05AX28

14 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
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.

Price per daily dose

What a daily dose of bulevirtide costs, country by country.

Normalised to the WHO defined daily dose (2 mg), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Bulevirtide · price per daily dose (2 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$219.16
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

HPRA (Ireland)
Active substance
Bulevirtide
Manufacturer
Gilead Sciences Ireland UC
Country
Ireland (IE)
ATC code
J05AX28
ATC class
Bulevirtide
Defined daily dose
2 mg, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/20/1446/001

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/6d3f6e73-e070-40ae-b2d6-b0a2e838f633
GET /v1/drugs/6d3f6e73-e070-40ae-b2d6-b0a2e838f633?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": "Powder for solution for injection",
  "routes": [
    "Subcutaneous use"
  ],
  "source": "hpra",
  "atc_all": [
    "J05A",
    "J05AX",
    "J05AX28"
  ],
  "strength": null,
  "pa_number": "EU/1/20/1446/001",
  "substances": [
    "Bulevirtide"
  ],
  "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "31/07/2020",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about bulevirtide.

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.