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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.

ATC L03

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedStrimvelis 1-10 x 10e6 cells/mL dispe…ATCL03REGISTER NO.IE-PA-EU/1/16/1097/001PACKS LISTED1CHECKEDSeptember 28, 2026

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_number
    EU/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.