Ireland· IE-PA-EU/1/25/1932/001-002
Ogsiveo 50 mg film‑coated tablets
A nirogacestat product containing nirogacestat hydrobromide, registered in Ireland by Merck Europe B.V.. The same ATC class is registered in 9 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Nirogacestat is registered in 9 of 19 countries.
Countries holding a registration under ATC L01XX81 (nirogacestat), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Nirogacestat · ATC L01XX81
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Spainprice
- Switzerlandprice
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Nirogacestat hydrobromide
- Manufacturer
- Merck Europe B.V.
- Country
- Ireland (IE)
- ATC code
- L01XX81
- ATC class
- Nirogacestat
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/1932/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Nirogacestat in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaOGSIVEOMerck Europe B.V., Amsterdam
- BelgiumOgsiveo 50 mgMerck Europe
- FinlandOgsiveoMerck Europe B.V.
- IcelandOgsiveoMerck Europe B.V.*
- PolandOgsiveoSpringWorks Therapeutics Ireland Limited
- SwedenOgsiveo 50 mg Filmdragerad tablettMerck Europe B.V.
- United StatesOGSIVEOSpringWorks Therapeutics, Inc.
- SpainOGSIVEO 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULAMerck Europe B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ogsiveo
- Liechtenstein · Ogsiveo
- Norway · Ogsiveo
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/5bc80e6b-d69a-4ed0-8b7c-6b608c0e5183 GET /v1/drugs/5bc80e6b-d69a-4ed0-8b7c-6b608c0e5183?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": "Film-coated tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"L01XX81"
],
"strength": null,
"pa_number": "EU/1/25/1932/001-002",
"substances": [
"Nirogacestat hydrobromide"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "14/08/2025",
"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 nirogacestat.
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.