Ireland· IE-PA-EU/1/16/1097/001
Strimvelis 1-10 x 10e6 cells/mL dispersion for infusion
A immunostimulants product containing autologous cd34+ enriched cell fraction, registered in Ireland by Fondazione Telethon Ets.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Autologous cd34+ enriched cell fraction
- Manufacturer
- Fondazione Telethon Ets
- Country
- Ireland (IE)
- ATC code
- L03
- ATC class
- IMMUNOSTIMULANTS
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/16/1097/001
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/b2c0e9f7-dcbd-4310-ac41-dad63915b736 GET /v1/drugs/b2c0e9f7-dcbd-4310-ac41-dad63915b736?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": [
"L03"
],
"strength": null,
"pa_number": "EU/1/16/1097/001",
"substances": [
"Autologous cd34+ enriched cell fraction"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "26/05/2016",
"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 autologous cd34+ enriched cell fraction.
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.