Ireland· IE-PA-EU/1/17/1234/001
Tremfya 100 mg Solution for injection pre-filled syringe
A immunosuppressants product containing guselkumab, registered in Ireland by Janssen-Cilag International NV. The same ATC class is registered in 3 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Guselkumab is registered in 3 of 19 countries.
Countries holding a registration under ATC L04A (immunosuppressants), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 2 of them publish a price we can compare per daily dose
Guselkumab · ATC L04A
3 / 19 countries
- Icelandprice
- Ireland
- Polandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Guselkumab
- Manufacturer
- Janssen-Cilag International NV
- Country
- Ireland (IE)
- ATC code
- L04A
- ATC class
- IMMUNOSUPPRESSANTS
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/17/1234/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Guselkumab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsTremfya 100 mg OnePress oplossing voor injectie in een voorgevulde penJanssen-Cilag International NV
- FranceTREMFYA 100 mg ONEPRESS, solution injectable en stylo prérempliJANSSEN CILAG INTERNATIONAL NV
- CzechiaTREMFYAJanssen-Cilag International N.V., Beerse
- SwitzerlandTremfya 100 mg/1 ml, Injektionslösung im FertigpenJanssen-Cilag AG
- IcelandTremfyaJanssen-Cilag International NV*
- BelgiumTremfya 100 mgJanssen-Cilag International
- FinlandTremfyaJanssen-Cilag International NV
- SwedenTremfya (OnePress) 100 mg Injektionsvätska, lösning i förfylld injektionspennaJanssen-Cilag International NV
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Tremfya
- Liechtenstein · Tremfya
- Norway · Tremfya
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/18c30e63-dc85-4e91-8774-a4d0b519e9d2 GET /v1/drugs/18c30e63-dc85-4e91-8774-a4d0b519e9d2?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 syringe",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"L04A"
],
"strength": null,
"pa_number": "EU/1/17/1234/001",
"substances": [
"Guselkumab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "10/11/2017",
"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 guselkumab.
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.