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Ireland· IE-PA-EU/1/23/1776/001

AGAMREE 40 mg/ml oral suspension

A vamorolone product containing vamorolone, registered in Ireland by Santhera Pharmaceuticals (Deutschland) GmbH. The same ATC class is registered in 11 of our 19 countries.

ATC H02AB18

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedAGAMREE 40 mg/ml oral suspensionATCH02AB18REGISTER NO.IE-PA-EU/1/23/1776/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Vamorolone is registered in 11 of 19 countries.

Countries holding a registration under ATC H02AB18 (vamorolone), each read from that country’s own register.

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

Vamorolone · ATC H02AB18

11 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
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
Vamorolone
Manufacturer
Santhera Pharmaceuticals (Deutschland) GmbH
Country
Ireland (IE)
ATC code
H02AB18
ATC class
Vamorolone
Defined daily dose
0.24 g, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/23/1776/001

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/c8bbd157-0da9-48fa-99f6-e61d1083ad21
GET /v1/drugs/c8bbd157-0da9-48fa-99f6-e61d1083ad21?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": "Oral suspension",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "H02AB18"
  ],
  "strength": null,
  "pa_number": "EU/1/23/1776/001",
  "substances": [
    "Vamorolone"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "14/12/2023",
  "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 vamorolone.

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.