Ireland· IE-PA-EU/1/14/984/001-005
Xadago 50 mg Film-coated tablet
A dopaminergic agents product containing safinamide methanesulfonate, registered in Ireland by Zambon S.p.A..
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Safinamide methanesulfonate
- Manufacturer
- Zambon S.p.A.
- Country
- Ireland (IE)
- ATC code
- N04B
- ATC class
- DOPAMINERGIC AGENTS
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/14/984/001-005
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Safinamide methanesulfonate in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainSAFINAMIDA AUROVITAS 50 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFGAurovitas Spain, S.A.U.
- SwedenOrvago 50 mg Filmdragerad tablettElpen Pharmaceutical Co. Inc
- CzechiaXADAGOZambon S.p.A., Bresso
- BelgiumSafinamide AB 50 mgAurobindo
- United StatesXadagoMDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
- SwitzerlandXadago 50 mg, compresse rivestite con filmZambon Svizzera SA
- FinlandSafinamide VivantaVivanta Generics s.r.o.
- NorwayXadagoZambon SpA
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Belgium · Safinamide Ab, Safinamide Eg
- Cyprus · Orvago
- Germany · Safinamid Al, Safinamid Puren
- Denmark · Safinamid Vivanta
- Estonia · Safinamide Teva
- Spain · Safinamida Aurovitas, Safinamida Cinfa
- Finland · Safinamide Vivanta
- United Kingdom (Northern Ireland) · Safinamide Amarox, Safinamide Milpharm
- Greece · Orvago, Safinamide Win Medica
- Croatia · Safinamid Msn, Safinamide Msn
- Iceland · Xadago
- Italy · Safinamide Aurobindo, Safinamide Doc
- Liechtenstein · Xadago
- Lithuania · Safinamide Teva
- Luxembourg · Safinamide Eg
- Latvia · Safinamide Teva
- Malta · Safinamide Nio
- Netherlands · Safinamide Vivanta
- Norway · Safinamide Vivanta, Xadago
- Portugal · Safinamida Aurobindo, Safinamida Generis
- Sweden · Orvago, Safinamid Doc
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/564508bd-a82f-4b4f-b23a-3752c6f807c0 GET /v1/drugs/564508bd-a82f-4b4f-b23a-3752c6f807c0?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": "Film-coated tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"N04B"
],
"strength": null,
"pa_number": "EU/1/14/984/001-005",
"substances": [
"Safinamide methanesulfonate"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "24/02/2015",
"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 safinamide methanesulfonate.
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.