Belgium· BE-AMP-SAM577857-00
Libmeldy 2 10*6 cells/ml - 10 10*6 cells/ml
A atidarsagene autotemcel product containing atidarsagene autotemcel - autologous cd34+ cell enriched population that contains hematopoietic stem and progenitor cells (hspc) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase a (arsa) gene, registered in Belgium by Orchard Therapeutics (Netherlands). The same ATC class is registered in 9 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Atidarsagene Autotemcel - Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A (ARSA) gene
- Manufacturer
- Orchard Therapeutics (Netherlands)
- Country
- Belgium (BE)
- ATC code
- A16AB21
- ATC class
- Atidarsagene autotemcel
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 1
- be_apb7739808
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.
- IcelandLibmeldyOrchard Therapeutics (Netherlands) B.V.
- 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
- NetherlandsLibmeldy 2-10 x 10^6 cellen/ml dispersie voor infusieOrchard Therapeutics (Netherlands) B.V.
- PolandLibmeldyOrchard Therapeutics (Netherlands) BV
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 FAMHP / AFMPS (Belgium). 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/32ac814c-aace-44b4-898b-24a9010b6a37 GET /v1/drugs/32ac814c-aace-44b4-898b-24a9010b6a37?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Libmeldy 2 10*6 cells/ml - 10 10*6 cells/ml",
"name_fr": "Libmeldy 2 10*6 cells/ml - 10 10*6 cells/ml",
"name_nl": "Libmeldy 2 10*6 cells/ml - 10 10*6 cells/ml",
"amp_code": "SAM577857-00",
"strengths": [
"55.0000",
"3.5000"
],
"pack_count": 1,
"substances": [
"Atidarsagene Autotemcel - Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A (ARSA) gene",
"Dimethyl Sulfoxide",
"Sodium"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Atidarsagene Autotemcel",
"authorisation_numbers": [
"EU/1/20/1493/001"
]
}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.