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.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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
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_numberEU/1/20/1493/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Atidarsagene autotemcel in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumLibmeldy 2 10*6 cells/ml - 10 10*6 cells/mlOrchard Therapeutics (Netherlands)
- IcelandLibmeldyOrchard Therapeutics (Netherlands) B.V.
- United StatesLENMELDYOrchard Therapeutics (Europe) Ltd
- FinlandLibmeldyOrchard Therapeutics (Netherlands) BV
- FranceLIBMELDY 2-10 x 1 000 000 cellules / ml, dispersion pour perfusionORCHARD THERAPEUTICS (NETHERLANDS) (PAYS-BAS)
- United KingdomLibmeldy 2million-10million cells/ml dispersion for infusion bagsOrchard Therapeutics (Europe) Ltd
- SwedenLibmeldy 2 - 10 miljoner celler/ml Infusionsvätska, dispersionOrchard Therapeutics (Netherlands) BV
- NetherlandsLibmeldy 2-10 x 10^6 cellen/ml dispersie voor infusieOrchard Therapeutics (Netherlands) B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Libmeldy, Strimvelis
- Liechtenstein · Libmeldy, Strimvelis
- Norway · Libmeldy, Strimvelis
Source: European Medicines Agency, Article 57 product data.
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.