Ireland· IE-PA-EU/1/24/1850/001-002
Winrevair 45 mg powder and solvent for solution for injection
A sotatercept product containing sotatercept, registered in Ireland by Merck Sharp & Dohme BV,. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Sotatercept is registered in 11 of 19 countries.
Countries holding a registration under ATC C02KX06 (sotatercept), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 5 of them publish a price we can compare per daily dose
Sotatercept · ATC C02KX06
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- United Kingdom
Price per daily dose
What a daily dose of sotatercept costs, country by country.
Normalised to the WHO defined daily dose (1 mg), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Sotatercept · price per daily dose (1 mg)
USD · FX 28 Sept 2026
- CH Switzerland$167.27
The record
At a glance
HPRA (Ireland)- Active substance
- Sotatercept
- Manufacturer
- Merck Sharp & Dohme BV,
- Country
- Ireland (IE)
- ATC code
- C02KX06
- ATC class
- Sotatercept
- Defined daily dose
- 1 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/24/1850/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
121 interactions on record for sotatercept.
Mechanism, severity and management for each pair, from a commercially licensed source — included with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Sotatercept · interactions on record
121 records
121 more interactions with mechanism and management, from a commercially licensed source.
Sign in to checkSame medicine, other countries
Sotatercept in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceWINREVAIR 45 mg, poudre et solvant pour solution injectableMERCK SHARP & DOHME (PAYS-BAS)
- NetherlandsWinrevair 45 mg poeder en oplosmiddel voor oplossing voor injectieMerck Sharp & Dohme B.V.
- CzechiaWINREVAIRMerck Sharp & Dohme B.V., Haarlem
- SwitzerlandWinrevair 45 mg, Pulver und Lösungsmittel zur Herstellung einer InjektionslösungMSD Merck Sharp & Dohme AG
- BelgiumWinrevair 45 mgMerck Sharp & Dohme
- FinlandWinrevairMerck Sharp & Dohme B.V.
- IcelandWinrevairMerck Sharp & Dohme B.V.*
- PolandWinrevairMerck Sharp & Dohme B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Winrevair
- Liechtenstein · Winrevair
- Norway · Winrevair
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/128189ba-86d1-4a7c-be98-724f6f43d6ee GET /v1/drugs/128189ba-86d1-4a7c-be98-724f6f43d6ee?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": "Powder and solvent for solution for injection",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"C02KX06"
],
"strength": null,
"pa_number": "EU/1/24/1850/001-002",
"substances": [
"Sotatercept"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "22/08/2024",
"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 sotatercept.
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.