Ireland· IE-PA-EU/1/23/1742/002
Columvi 10 mg concentrate for solution for infusion
A glofitamab product containing glofitamab, registered in Ireland by Roche Registration GmbH. The same ATC class is registered in 13 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Glofitamab is registered in 13 of 19 countries.
Countries holding a registration under ATC L01FX28 (glofitamab), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 9 of them publish a price we can compare per daily dose
Glofitamab · ATC L01FX28
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Glofitamab
- Manufacturer
- Roche Registration GmbH
- Country
- Ireland (IE)
- ATC code
- L01FX28
- ATC class
- Glofitamab
- Defined daily dose
- 1.43 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/23/1742/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Glofitamab in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumColumvi 10 mgRoche Registration
- CzechiaCOLUMVIRoche Registration GmbH, Grenzach-Wyhlen
- FinlandColumviRoche Registration GmbH
- IcelandColumviRoche Registration GmbH*
- NorwayColumviRoche Registration GmbH
- PolandColumviRoche Registration GmbH
- SwedenColumvi 10 mg Koncentrat till infusionsvätska, lösningRoche Registration GmbH
- United StatesColumviGenentech, Inc.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Columvi
- Liechtenstein · Columvi
- Norway · Columvi
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/b5c4d2f0-aaef-473c-9778-06a74a115f2d GET /v1/drugs/b5c4d2f0-aaef-473c-9778-06a74a115f2d?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": [
"L01",
"L01FX28"
],
"strength": null,
"pa_number": "EU/1/23/1742/002",
"substances": [
"Glofitamab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "07/07/2023",
"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 glofitamab.
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.