Ireland· IE-PA-EU/1/21/1538/001
JEMPERLI 500 mg concentrate for solution for infusion
A dostarlimab product containing dostarlimab, registered in Ireland by GlaxoSmithKline Trading Services Limited.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Dostarlimab
- Manufacturer
- GlaxoSmithKline Trading Services Limited
- Country
- Ireland (IE)
- ATC code
- L01XC40
- ATC class
- Dostarlimab
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/21/1538/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dostarlimab in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandJEMPERLIOrifarm Oy
- BelgiumJemperli 500 mgGlaxoSmithKline Trading Services
- CzechiaJEMPERLIGlaxoSmithKline Trading Services Limited, Dublin
- IcelandJemperliGlaxoSmithKline Trading Services Limited
- NorwayJemperliGlaxoSmithKline Trading Services Limited
- SwedenJemperli 500 mg Koncentrat till infusionsvätska, lösningGlaxoSmithKline Trading Services Ltd
- SpainJEMPERLI 500 mg CONCENTRADO PARA SOLUCION PARA PERFUSIONGlaxosmithkline Trading Services Limited
- SwitzerlandJemperli
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Jemperli
- Liechtenstein · Jemperli
- Norway · Jemperli
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/114713b3-72d9-4244-bd4e-1ce41fe68684 GET /v1/drugs/114713b3-72d9-4244-bd4e-1ce41fe68684?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": [
"L01XC",
"L01XC40"
],
"strength": null,
"pa_number": "EU/1/21/1538/001",
"substances": [
"Dostarlimab"
],
"legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "21/04/2021",
"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 dostarlimab.
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.