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Ireland· IE-PA-EU/1/14/987/001

Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent

A limbale stammzellen, autolog product containing ex vivo expanded autologous corneal epithelial cells containing stem cells, registered in Ireland by Holostem S.r.l.. The same ATC class is registered in 8 of our 19 countries.

ATC S01XA19

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedHoloclar 79,000 - 316,000 cells/cm2 l…ATCS01XA19REGISTER NO.IE-PA-EU/1/14/987/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Limbale stammzellen, autolog is registered in 8 of 19 countries.

Countries holding a registration under ATC S01XA19 (limbale stammzellen, autolog), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 5 of them publish a price we can compare per daily dose

Limbale stammzellen, autolog · ATC S01XA19

8 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Ex vivo expanded autologous corneal epithelial cells containing stem cells
Manufacturer
Holostem S.r.l.
Country
Ireland (IE)
ATC code
S01XA19
ATC class
Limbale Stammzellen, autolog
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/14/987/001

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/c27c8bb5-8c21-400f-9538-0a5a445f2033
GET /v1/drugs/c27c8bb5-8c21-400f-9538-0a5a445f2033?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": "Living tissue equivalent",
  "routes": [
    "Implantation"
  ],
  "source": "hpra",
  "atc_all": [
    "S01XA19"
  ],
  "strength": null,
  "pa_number": "EU/1/14/987/001",
  "substances": [
    "Ex vivo expanded autologous corneal epithelial cells containing stem cells"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": null,
  "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 limbale stammzellen, autolog.

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.