Ireland· IE-PA-EU/1/19/1376/001
LIBTAYO 350 mg Concentrate for solution for infusion
A cemiplimab product containing cemiplimab, registered in Ireland by Regeneron Ireland U.C..
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- CEMIPLIMAB
- Manufacturer
- Regeneron Ireland U.C.
- Country
- Ireland (IE)
- ATC code
- L01XC33
- ATC class
- Cemiplimab
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/19/1376/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
17 interactions on record for cemiplimab.
Graded by severity as the source publishes them — 17 moderate. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Cemiplimab · interactions on record
17 records
- 17 moderate
Most severe, free to view
- PrednisoloneA07EA01moderate
- HydrocortisoneA07EA02moderate
- PrednisoneA07EA03moderate
- BetamethasoneA07EA04moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Cemiplimab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandLIBTAYOOrifarm Oy
- NorwayLibtayoRegeneron Ireland Designated Activity Company (DAC)
- BelgiumLibtayo 350 mgRegeneron Ireland Designated Activity Company (DAC)
- PolandLibtayoRegeneron Ireland Designated Activity Company (DAC)
- SwedenLIBTAYO 350 mg Koncentrat till infusionsvätska, lösningRegeneron Ireland Designated Activity Company
- IcelandLibtayoRegeneron Ireland Designated Activity Company
- CzechiaLIBTAYORegeneron Ireland Designated Activity Company, Dublin
- SpainLIBTAYO 350 MG CONCENTRADO PARA SOLUCION PARA PERFUSIONRegeneron Ireland Designated Activity Company
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Libtayo
- Liechtenstein · Libtayo
- Norway · Libtayo
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/3698ea11-5ac3-474e-8d31-a65ac024a2e7 GET /v1/drugs/3698ea11-5ac3-474e-8d31-a65ac024a2e7?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": "Concentrate for solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"L01XC33"
],
"strength": null,
"pa_number": "EU/1/19/1376/001",
"substances": [
"CEMIPLIMAB"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "28/06/2019",
"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 cemiplimab.
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.