Ireland· IE-PA-EU/1/25/2007/001
EXDENSUR 100 mg solution for injection in pre-filled pen
A depemokimab product containing depemokimab, registered in Ireland by GlaxoSmithKline Trading Services Limited. The same ATC class is registered in 9 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Depemokimab is registered in 9 of 19 countries.
Countries holding a registration under ATC R03DX12 (depemokimab), 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
Depemokimab · ATC R03DX12
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Japan
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Depemokimab
- Manufacturer
- GlaxoSmithKline Trading Services Limited
- Country
- Ireland (IE)
- ATC code
- R03DX12
- ATC class
- Depemokimab
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/2007/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Depemokimab in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsEXDENSUR 100 mg oplossing voor injectie in een voorgevulde penGlaxoSmithKline Trading Services Limited
- United StatesExdensurGlaxoSmithKline LLC
- CzechiaEXDENSURGlaxoSmithKline Trading Services Limited, Dublin
- SpainEXDENSUR 100 MG SOLUCION INYECTABLE EN JERINGA PRECARGADAGlaxosmithkline Trading Services Limited
- FinlandEXDENSURGlaxoSmithKline Trading Services Limited
- United KingdomExdensur 100mg/1ml solution for injection pre-filled pensGlaxoSmithKline UK Ltd
- BelgiumExdensur 100 mgGlaxoSmithKline Trading Services
- IcelandEXDENSURGlaxoSmithKline Trading Services Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Exdensur
- Liechtenstein · Exdensur
- Norway · Exdensur
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/4c094a18-b42c-4df2-81eb-bd7c6e3a8788 GET /v1/drugs/4c094a18-b42c-4df2-81eb-bd7c6e3a8788?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": "Solution for injection in pre-filled pen",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"R03DX12"
],
"strength": null,
"pa_number": "EU/1/25/2007/001",
"substances": [
"Depemokimab"
],
"legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "12/02/2026",
"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 depemokimab.
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.