Ireland· IE-PA-EU/1/21/1544/001
Orladeyo 150 mg hard capsules
A berotralstat product containing berotralstat hydrochloride + berotralstat, registered in Ireland by BioCryst Ireland Ltd. The same ATC class is registered in 17 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Berotralstat is registered in 17 of 19 countries.
Countries holding a registration under ATC B06AC06 (berotralstat), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 11 of them publish a price we can compare per daily dose
Berotralstat · ATC B06AC06
17 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of berotralstat costs, country by country.
Normalised to the WHO defined daily dose (0.15 g), 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
Berotralstat · price per daily dose (0.15 g)
USD · FX 28 Sept 2026
- CH Switzerland$576.89
The record
At a glance
HPRA (Ireland)- Active substance
- Berotralstat hydrochloride + Berotralstat
- Manufacturer
- BioCryst Ireland Ltd
- Country
- Ireland (IE)
- ATC code
- B06AC06
- ATC class
- Berotralstat
- Defined daily dose
- 0.15 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/21/1544/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
209 interactions on record for berotralstat.
Graded by severity as the source publishes them — 66 severe. Severity grades are free for everyone; mechanism and management come 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
Berotralstat · interactions on record
209 records
- 66 severe
- 132 moderate
- 11 minor
Most severe, free to view
- RolapitantA04AD14severe
- NaloxegolA06AH03severe
- FidaxomicinA07AA12severe
- EliglustatA16AX10severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
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.
- United StatesOrladeyoBioCryst Pharmaceuticals, Inc.
- CzechiaORLADEYOBIOCRYST IRELAND LIMITED, Dublin
- BelgiumOrladeyo 108 mgBiocryst Ireland
- FinlandOrladeyoBioCryst Ireland Limited
- NetherlandsOrladeyo 108 mg filmomhuld granulaat in sachetBioCryst Ireland Limited
- SwedenOrladeyo 108 mg Filmdragerat granulat i dospåseBioCryst Ireland Limited
- FranceORLADEYO 150 mg, géluleBIOCRYST IRELAND LIMITED (IRLANDE)
- United KingdomOrladeyo 150mg 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 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/eef56d48-2e9d-427c-a580-d5ebfe1d0243 GET /v1/drugs/eef56d48-2e9d-427c-a580-d5ebfe1d0243?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": "Capsule, hard",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"B06AC06"
],
"strength": null,
"pa_number": "EU/1/21/1544/001",
"substances": [
"Berotralstat hydrochloride",
"Berotralstat"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "30/04/2021",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}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.