Iceland· IS-EU/1/20/1493/001
Libmeldy
A atidarsagene autotemcel product containing atidarsagenum autotemcelum inn, registered in Iceland by Orchard Therapeutics (Netherlands) B.V.. The same ATC class is registered in 9 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Atidarsagenum autotemcelum INN
- Manufacturer
- Orchard Therapeutics (Netherlands) B.V.
- Country
- Iceland (IS)
- ATC code
- A16AB21
- ATC class
- Atidarsagene autotemcel
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 0
No packs listed by the register for this record.
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)
- United StatesLENMELDYOrchard Therapeutics (Europe) Ltd
- SpainLIBMELDY 2-10 X 10^6 CELULAS/ML DISPERSION PARA PERFUSIONOrchard Therapeutics (Netherlands) B.V.
- 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
- IrelandLibmeldy 2-10 x 106 cells/mL dispersion for infusionOrchard Therapeutics (Netherlands) B.V.
- 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 2 EEA countries. Names it is sold under:
- 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 Icelandic Medicines Agency (Iceland). 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/994cb3f4-6557-4b1d-99b8-854755532aef GET /v1/drugs/994cb3f4-6557-4b1d-99b8-854755532aef?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": "Innrennslislyf, ördreifa",
"source": "lyfjastofnun",
"atc_raw": "A16AB21",
"marketed": false,
"strength": "2 10 x 10e6 frumur/ml",
"ma_number": "EU/1/20/1493/001",
"substance": "Atidarsagenum autotemcelum INN",
"other_info": "Markaðssetning á Íslandi er háð því að Lyfjastofnun hafi staðfest að sérstök skilyrði er varða öryggi og verkun við notkun lyfsins séu uppfyllt.",
"legal_status": "(R) Lyfseðilsskylt\r\n(H) Sjúkrahúsmerkt",
"ma_issued_serial": "44182"
}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.