Ireland· IE-PA-EU/1/20/1505/001
Byfavo 20 mg powder for solution for injection
A benzodiazepine derivatives product containing remimazolam besilate + remimazolam (in house), registered in Ireland by Paion Pharma GmbH.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Remimazolam besilate + Remimazolam (in house)
- Manufacturer
- Paion Pharma GmbH
- Country
- Ireland (IE)
- ATC code
- N05CD
- ATC class
- Benzodiazepine derivatives
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/20/1505/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Remimazolam besilate + remimazolam (in house) in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NorwayByfavoPaion
- CzechiaBYFAVOPAION Pharma GmbH, Aachen
- FinlandByfavoPAION Pharma GmbH
- BelgiumByfavo 20 mgPaion Pharma
- Japanレミマゾラムベシル酸塩ムンディファーマ
- NetherlandsByfavo 20 mg, poeder voor oplossing for injectie of infusiePaion Pharma GmbH
- PolandByfavoPAION Deutschland GmbH
- SwedenByfavo 20 mg Pulver till injektionsvätska, lösningPAION Pharma GmbH
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Byfavo
- Liechtenstein · Byfavo
- Norway · Byfavo
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/b2802967-d0e5-42d9-8143-596496b8966c GET /v1/drugs/b2802967-d0e5-42d9-8143-596496b8966c?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 for solution for injection",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"N05CD"
],
"strength": null,
"pa_number": "EU/1/20/1505/001",
"substances": [
"Remimazolam besilate",
"Remimazolam (in house)"
],
"legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "26/03/2021",
"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 remimazolam besilate + remimazolam (in house).
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.