Ireland· IE-PA-EU/1/22/1679/001
Opdualag 240 mg/80 mg sterile concentrate
A nivolumab und relatlimab product containing relatlimab + nivolumab, registered in Ireland by Bristol-Myers Squibb Pharma EEIG.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- RELATLIMAB + Nivolumab
- Manufacturer
- Bristol-Myers Squibb Pharma EEIG
- Country
- Ireland (IE)
- ATC code
- L01XY03
- ATC class
- Nivolumab und Relatlimab
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/22/1679/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Nivolumab und relatlimab in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaOPDUALAGBRISTOL-MYERS SQUIBB CANADA
- SwitzerlandOpdualag (80 mg Relatlimab / 240 mg Nivolumab pro 20 ml), Konzentrat zur Herstellung einer InfusionslösungBristol-Myers Squibb SA
- CzechiaOPDUALAGBristol-Myers Squibb Pharma EEIG, Dublin
- SpainOPDUALAG 240 MG/80 MG CONCENTRADO PARA SOLUCION PARA PERFUSIONBristol-Myers Squibb Pharma Eeig
- FinlandOpdualagBristol-Myers Squibb Pharma EEIG
- FranceOPDUALAG 240 mg/80 mg, solution à diluer pour perfusionBRISTOL-MYERS SQUIBB / PFIZER EEIG (IRLANDE)
- United KingdomOpdualag 240mg/20ml / 80mg/20ml concentrate for solution for infusion vialsBristol-Myers Squibb Pharmaceuticals Ltd
- IcelandOpdualagBristol-Myers Squibb Pharma EEIG*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Opdualag
- Liechtenstein · Opdualag
- Norway · Opdualag
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/bcc90651-fadf-4e25-a0f5-1b413d258924 GET /v1/drugs/bcc90651-fadf-4e25-a0f5-1b413d258924?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": [
"L01XY",
"L01XY03"
],
"strength": null,
"pa_number": "EU/1/22/1679/001",
"substances": [
"RELATLIMAB",
"Nivolumab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "15/06/2022",
"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 nivolumab und relatlimab.
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.