Ireland· IE-PA-EU/1/25/1975/001-002
Ekterly 300 mg film-coated tablets
A sebetralstat product containing sebetralstat, registered in Ireland by Kalvista Pharmaceuticals (Ireland) Limited. 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
Sebetralstat is registered in 9 of 19 countries.
Countries holding a registration under ATC B06AC08 (sebetralstat), 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
Sebetralstat · ATC B06AC08
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Finlandprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Switzerlandprice
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Sebetralstat
- Manufacturer
- Kalvista Pharmaceuticals (Ireland) Limited
- Country
- Ireland (IE)
- ATC code
- B06AC08
- ATC class
- Sebetralstat
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/1975/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sebetralstat in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaEKTERLYKalVista Pharmaceuticals (Ireland) Ltd., Dublin
- SwitzerlandEkterly 300 mg, FilmtablettenKalVista Pharmaceuticals Switzerland GmbH
- IcelandEkterlyKalvista Pharmaceuticals (Ireland) Limited
- NetherlandsEkterly 300 mg filmomhulde tablettenKalvista Pharmaceuticals (Ireland) Limited
- PolandEkterlyKalVista Pharmaceuticals (Ireland) Ltd.
- BelgiumEkterly 300 mgKalvista Pharmaceuticals (Ireland)
- SwedenEkterly 300 mg Filmdragerad tablettKalvista Pharmaceuticals (Ireland) Limited
- FinlandEkterlyKalvista Pharmaceuticals (Ireland) Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ekterly
- Liechtenstein · Ekterly
- Norway · Ekterly
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/b451ed98-9783-434c-98b0-f26b161be393 GET /v1/drugs/b451ed98-9783-434c-98b0-f26b161be393?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": [
"B06AC08"
],
"strength": null,
"pa_number": "EU/1/25/1975/001-002",
"substances": [
"Sebetralstat"
],
"legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "17/09/2025",
"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 sebetralstat.
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.