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.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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
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_numberEU/1/23/1776/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Vamorolone in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumAgamree 40 mg/mlSanthera Pharmaceuticals (Deutschland)
- SwitzerlandAgamree 40 mg/ml, Suspension zum EinnehmenSanthera Pharmaceuticals (Schweiz) AG
- CzechiaAGAMREESanthera Pharmaceuticals (Deutschland) GmbH, Lörrach
- SpainAGAMREE 40 MG/ML SUSPENSION ORALSanthera Pharmaceuticals Gmbh
- FinlandAGAMREESanthera Pharmaceuticals (Deutschland) GmbH
- IcelandAgamreeSanthera Pharmaceuticals (Deutschland) GmbH
- NetherlandsAGAMREE 40 mg/ml suspensie voor oraal gebruikSanthera Pharmaceuticals (Deutschland) GmbH
- NorwayAgamreeSanthera Pharmaceuticals (Deutschland) GmbH
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Agamree
- Liechtenstein · Agamree
- Norway · Agamree
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 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.