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Ireland· IE-PA-EU/1/20/1493/001

Libmeldy 2-10 x 106 cells/mL dispersion for infusion

A atidarsagene autotemcel product containing autologous cd34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase a gene, registered in Ireland by Orchard Therapeutics (Netherlands) B.V.. The same ATC class is registered in 9 of our 19 countries.

ATC A16AB21

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedLibmeldy 2-10 x 106 cells/mL dispersi…ATCA16AB21REGISTER NO.IE-PA-EU/1/20/1493/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Atidarsagene autotemcel is registered in 9 of 19 countries.

Countries holding a registration under ATC A16AB21 (atidarsagene autotemcel), each read from that country’s own register.

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

Atidarsagene autotemcel · ATC A16AB21

9 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Polandprice
  • 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.

The record

At a glance

HPRA (Ireland)
Active substance
Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the Human Arylsulfatase a Gene
Manufacturer
Orchard Therapeutics (Netherlands) B.V.
Country
Ireland (IE)
ATC code
A16AB21
ATC class
Atidarsagene autotemcel
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/20/1493/001

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/2b9fd6bb-343a-40c2-b52a-4fddcbbcded2
GET /v1/drugs/2b9fd6bb-343a-40c2-b52a-4fddcbbcded2?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": "Dispersion for infusion",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "A16AB21"
  ],
  "strength": null,
  "pa_number": "EU/1/20/1493/001",
  "substances": [
    "Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the Human Arylsulfatase a Gene"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "17/12/2020",
  "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 atidarsagene autotemcel.

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.