Poland· PL-100504854
Winrevair
A antihypertensives for pulmonary arterial hypertension product containing sotaterceptum, registered in Poland by Merck Sharp & Dohme B.V.. The same ATC class is registered in 3 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Sotaterceptum is registered in 3 of 19 countries.
Countries holding a registration under ATC C02KX (antihypertensives for pulmonary arterial hypertension), each read from that country’s own register.
- This record: Poland, from URPL (Poland)
- 2 of them publish a price we can compare per daily dose
Sotaterceptum · ATC C02KX
3 / 19 countries
- Canada
- Polandprice
- Switzerlandprice
The record
At a glance
URPL (Poland)- Active substance
- Sotaterceptum
- Manufacturer
- Merck Sharp & Dohme B.V.
- Country
- Poland (PL)
- ATC code
- C02KX
- ATC class
- Antihypertensives for pulmonary arterial hypertension
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 2
- gtin00191778024401
- gtin00191778024388
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sotaterceptum in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IcelandWinrevairMerck Sharp & Dohme B.V.*
- CzechiaWINREVAIRMerck Sharp & Dohme B.V., Haarlem
- SwedenWinrevair 60 mg Pulver och vätska till injektionsvätska, lösningMerck Sharp & Dohme BV
- BelgiumWinrevair 60 mgMerck Sharp & Dohme
- United KingdomWinrevair 60mg powder and solvent for solution for injection vialsMerck Sharp & Dohme (UK) Ltd
- SpainWINREVAIR 60 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLEMerck Sharp & Dohme B.V.
- SwitzerlandWinrevair 45 mg, Pulver und Lösungsmittel zur Herstellung einer InjektionslösungMSD Merck Sharp & Dohme AG
- FinlandWinrevairMerck 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 URPL (Poland). 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/541554ad-cdee-4309-a324-33ab068236a6 GET /v1/drugs/541554ad-cdee-4309-a324-33ab068236a6?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": "Proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań",
"source": "urpl",
"strength": "60 mg",
"packaging": "00191778024401 ¦ Rpz ¦ EU/1/24/1850/004 ¦ 157885\n2 amp.-strzyk. 1,3 ml rozpuszczalnika ¦ 1 strzykawka dozującą z podziałką + 2 adaptery fiolki (13 mm), 1 igłę do wstrzykiwań i 8 wacików nasączonych alkoholem. ¦ 2 fiol. 60 mg\n00191778024388 ¦ Rpz ¦ EU/1/24/1850/003 ¦ 157886\n1 fiol. 60 mg ¦ 1 amp.-strzyk. 1,3 ml rozpuszczalnika ¦ 1 strzykawka dozującą z podziałką + 1 adapter fiolki (13 mm), 1 igłę do wstrzykiwań i 4 waciki nasączone alkoholem.",
"substance": "Sotaterceptum 60 mg",
"common_name": "Sotaterceptum",
"pl_product_id": "100504854",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}See everything about sotaterceptum.
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.