Sweden· SE-20200311000025
Orladeyo 150 mg Kapsel, hård
A medicinal product containing berotralstat, registered in Sweden by BioCryst Ireland Limited.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Berotralstat
- Manufacturer
- BioCryst Ireland Limited
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20200311000025
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Berotralstat in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaORLADEYOBIOCRYST IRELAND LIMITED, Dublin
- United StatesOrladeyoBioCryst Pharmaceuticals, Inc.
- SwitzerlandOrladeyo 150 mg, HartkapselnBioCryst Schweiz GmbH
- SpainORLADEYO 150 MG CAPSULAS DURASBiocryst Ireland Limited
- FinlandOrladeyoBioCryst Ireland Limited
- BelgiumOrladeyo 150 mgBiocryst Ireland
- United KingdomOrladeyo 150mg capsulesBioCryst Ireland Ltd
- IcelandOrladeyoBioCryst Ireland Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Orladeyo
- Liechtenstein · Orladeyo
- Norway · Orladeyo
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 Swedish Medical Products Agency (Sweden). 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/be1979b0-ee75-4217-982c-39acabe96294 GET /v1/drugs/be1979b0-ee75-4217-982c-39acabe96294?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.
{
"source": "lakemedelsverket",
"doc_types": [
"Dispensbeslut",
"EPAR",
"EMA"
],
"se_npl_id": "20200311000025",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20200311000025",
"product_doc_link": "https://docetp.mpa.se/LMF/Orladeyo%2C%20kartong%20f%C3%B6r%20blister%2C%2028%20kapslar%2C%20sammanfattning%20av%20beslut%2C%20giltigt%20from%202025-05-27%20t%20o%20m%202027-05-27_09001bee84a49286.pdf"
}See everything about berotralstat.
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.