Sweden· SE-20250502000259
Orladeyo 108 mg Filmdragerat granulat i dospåse
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_varunummer20250502000259
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.
- BelgiumOrladeyo 108 mgBiocryst Ireland
- CzechiaORLADEYOBIOCRYST IRELAND LIMITED, Dublin
- FinlandOrladeyoBioCryst Ireland Limited
- NetherlandsOrladeyo 108 mg filmomhuld granulaat in sachetBioCryst Ireland Limited
- United StatesOrladeyoBioCryst Pharmaceuticals, Inc.
- FranceORLADEYO 150 mg, géluleBIOCRYST IRELAND LIMITED (IRLANDE)
- United KingdomOrladeyo 150mg capsulesBioCryst Ireland Ltd
- IrelandOrladeyo 150 mg hard capsulesBioCryst Ireland Ltd
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/65a41698-4b38-4676-9bd5-e8ded160bc5d GET /v1/drugs/65a41698-4b38-4676-9bd5-e8ded160bc5d?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": [
"EPAR",
"EMA"
],
"se_npl_id": "20250502000259",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20250502000259",
"product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/orladeyo-epar-product-information_sv.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.