Ireland· IE-PA-EU/1/25/1993/001
Vysribli (previously known as Denosumab Intas) 60 mg solution for injection in pre-filled syringe
A denosumab product containing denosumab, registered in Ireland by Intas Third Party Sales 2005 S.L.. The same ATC class is registered in 16 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Denosumab is registered in 16 of 19 countries.
Countries holding a registration under ATC M05BX04 (denosumab), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 10 of them publish a price we can compare per daily dose
Denosumab · ATC M05BX04
16 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of denosumab costs, country by country.
Normalised to the WHO defined daily dose (0.33 mg), 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
Denosumab · price per daily dose (0.33 mg)
USD · FX 28 Sept 2026
- CH Switzerland$1.37
The record
At a glance
HPRA (Ireland)- Active substance
- Denosumab
- Manufacturer
- Intas Third Party Sales 2005 S.L.
- Country
- Ireland (IE)
- ATC code
- M05BX04
- ATC class
- Denosumab
- Defined daily dose
- 0.33 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/1993/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
262 interactions on record for denosumab.
Graded by severity as the source publishes them — 3 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
Denosumab · interactions on record
262 records
- 3 severe
- 259 moderate
Most severe, free to view
- EtelcalcetideH05BX04severe
- CladribineL01BB04severe
- PrednisoloneA07EA01moderate
- HydrocortisoneA07EA02moderate
- 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
Denosumab in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsAcvybra 60 mg oplossing voor injectie in een voorgevulde spuitReddy Holding GmbH
- FranceACVYBRA 60 mg, solution injectable en seringue préremplieREDDY HOLDING (ALLEMAGNE)
- SwitzerlandDenosumab Zentiva 60 mg, Injektionslösung (s.c.)Helvepharm AG
- CzechiaACVYBRAReddy Holding GmbH, Augsburg
- BelgiumAcvybra 60 mgReddy Holding
- FinlandAcvybraReddy Holding GmbH
- SwedenAcvybra 60 mg Injektionsvätska, lösning i förfylld sprutaReddy Holding GmbH
- PolandAcvybraReddy Holding GmbH
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- United Kingdom (Northern Ireland) · Enwylma, Ponlimsi
- Iceland · Bildyos, Bilprevda
- Liechtenstein · Bildyos, Bilprevda
- Norway · Bildyos, Bilprevda
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/e3a14122-d894-468e-9e57-e9c9bad4e88d GET /v1/drugs/e3a14122-d894-468e-9e57-e9c9bad4e88d?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": "Solution for injection",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"M05BX04"
],
"strength": null,
"pa_number": "EU/1/25/1993/001",
"substances": [
"Denosumab"
],
"legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "17/11/2025",
"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 denosumab.
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.