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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.

ATC N05CD

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedByfavo 20 mg powder for solution for …ATCN05CDREGISTER NO.IE-PA-EU/1/20/1505/001PACKS LISTED1CHECKEDSeptember 28, 2026

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_number
    EU/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.

All remimazolam besilate + remimazolam (in house) products

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.