Ireland· IE-PA-EU/1/20/1500/005
Xofluza 2 mg/mL granules for oral suspension
A baloxavir marboxil product containing baloxavir marboxil, registered in Ireland by Roche Registration GmbH. The same ATC class is registered in 13 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Baloxavir marboxil is registered in 13 of 19 countries.
Countries holding a registration under ATC J05AX25 (baloxavir marboxil), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Baloxavir marboxil · ATC J05AX25
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- Spainprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Baloxavir Marboxil
- Manufacturer
- Roche Registration GmbH
- Country
- Ireland (IE)
- ATC code
- J05AX25
- ATC class
- Baloxavir marboxil
- Defined daily dose
- 40 mg, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/20/1500/005
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
40 interactions on record for baloxavir marboxil.
Graded by severity as the source publishes them — 40 moderate. 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
Baloxavir marboxil · interactions on record
40 records
- 40 moderate
Most severe, free to view
- Magnesium carbonateA02AA01moderate
- Magnesium oxideA02AA02moderate
- Magnesium hydroxideA02AA04moderate
- Kombinationen von AluminiumsalzenA02AB10moderate
- 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
Baloxavir marboxil in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumXofluza 2 mg/mlRoche Registration
- CzechiaXOFLUZARoche Registration GmbH, Grenzach-Wyhlen
- IcelandXofluzaRoche Registration GmbH*
- NetherlandsXofluza 2 mg/ml, granulaat voor orale suspensieRoche Registration GmbH
- SwedenXofluza 2 mg/ml Granulat till oral suspensionRoche Registration GmbH
- SwitzerlandXofluza 10 mg, Granulat zur Herstellung einer Suspension zum Einnehmen (Beutel)Roche Pharma (Schweiz) AG
- FinlandXofluzaRoche Registration GmbH
- United StatesXofluzaSportpharm LLC
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Xofluza
- Liechtenstein · Xofluza
- Norway · Xofluza
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/c080bac0-86a9-4fbe-bb7b-1bcee73fd1c5 GET /v1/drugs/c080bac0-86a9-4fbe-bb7b-1bcee73fd1c5?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": "Granules for oral suspension",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"J05AX25"
],
"strength": null,
"pa_number": "EU/1/20/1500/005",
"substances": [
"Baloxavir Marboxil"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "07/01/2021",
"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 baloxavir marboxil.
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.