Ireland· IE-PA-EU/1/25/1989/001-002
Imaavy 185 mg/mL concentrate for solution for infusion
A nipocalimab product containing nipocalimab, registered in Ireland by Janssen-Cilag International NV. The same ATC class is registered in 8 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Nipocalimab is registered in 8 of 19 countries.
Countries holding a registration under ATC L04AL03 (nipocalimab), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 6 of them publish a price we can compare per daily dose
Nipocalimab · ATC L04AL03
8 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Switzerlandprice
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Nipocalimab
- Manufacturer
- Janssen-Cilag International NV
- Country
- Ireland (IE)
- ATC code
- L04AL03
- ATC class
- Nipocalimab
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/1989/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Nipocalimab in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesIMAAVYJanssen Biotech, Inc.
- CzechiaIMAAVYJanssen-Cilag International N.V., Beerse
- BelgiumImaavy 185 mg/mlJanssen-Cilag International
- SwedenImaavy 185 mg/ml Koncentrat till infusionsvätska, lösningJanssen-Cilag International NV
- IcelandIMAAVYJanssen Cilag International
- FinlandImaavyJanssen Cilag International
- PolandImaavyJanssen-Cilag International N.V.
- SwitzerlandImaavy 1200 mg/6.5 ml (185 mg/ml), Konzentrat zur Herstellung einer InfusionslösungJanssen-Cilag AG
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Imaavy
- Liechtenstein · Imaavy
- Norway · Imaavy
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/c26396bf-a435-4626-941d-a5ce77a06803 GET /v1/drugs/c26396bf-a435-4626-941d-a5ce77a06803?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": [
"L04AL03"
],
"strength": null,
"pa_number": "EU/1/25/1989/001-002",
"substances": [
"Nipocalimab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "28/11/2025",
"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 nipocalimab.
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.