Poland· PL-100338983
Xadago
A safinamide product containing safinamidum, registered in Poland by Zambon S.p.A.. The same ATC class is registered in 17 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Safinamide is registered in 17 of 19 countries.
Countries holding a registration under ATC N04BD03 (safinamide), each read from that country’s own register.
- This record: Poland, from URPL (Poland)
- 10 of them publish a price we can compare per daily dose
Safinamide · ATC N04BD03
17 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of safinamide costs, country by country.
Normalised to the WHO defined daily dose (75 mg), the median price runs from $2.78 in Spain to $5.29 in Italy — a ×1.9 gap.
- 3 markets with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Safinamide · price per daily dose (75 mg)
USD · FX 28 Sept 2026
- IT Italy$5.29
- CH Switzerland$4.79
- ES Spain$2.78
The record
At a glance
URPL (Poland)- Active substance
- Safinamidum
- Manufacturer
- Zambon S.p.A.
- Country
- Poland (PL)
- ATC code
- N04BD03
- ATC class
- Safinamide
- Defined daily dose
- 75 mg, O
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 2
- gtin08031609002333
- gtin08031609002340
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
158 interactions on record for safinamide.
Graded by severity as the source publishes them — 18 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
Safinamide · interactions on record
158 records
- 18 severe
- 140 moderate
Most severe, free to view
- FenfluramineA08AA02severe
- DexfenfluramineA08AA04severe
- SibutramineA08AA10severe
- DoxepinD04AX01severe
- 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
Safinamide in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainSAFINAMIDA AUROVITAS 100 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFGAurovitas Spain, S.A.U.
- SwedenOrvago 100 mg Filmdragerad tablettElpen Pharmaceutical Co. Inc
- CzechiaXADAGOZambon S.p.A., Bresso
- BelgiumSafinamide AB 100 mgAurobindo
- United StatesXadagoMDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
- SwitzerlandXadago 100 mg, compresse rivestite con filmZambon Svizzera SA
- FinlandSafinamide VivantaVivanta Generics s.r.o.
- NetherlandsSafinamide Vivanta 100 mg filmomhulde tablettenVivanta Generics s.r.o.
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 URPL (Poland). 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/ac37ba08-8286-435c-bbdf-a7a01d71c8ff GET /v1/drugs/ac37ba08-8286-435c-bbdf-a7a01d71c8ff?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": "Tabletki powlekane",
"source": "urpl",
"strength": "100 mg",
"packaging": "08031609002333 ¦ Rp ¦ Eu/1/14/984/006 ¦ 107405\n14 tabl.\nRp ¦ EU/1/14/984/007 ¦ 107406\n28 tabl.\n08031609002340 ¦ Rp ¦ EU/1/14/984/008 ¦ 107407\n30 tabl.\nRp ¦ EU/1/14/984/009 ¦ 107408\n90 tabl.\nRp ¦ EU/1/14/984/010 ¦ 107409\n100 tabl.",
"substance": "Safinamidum 100 mg",
"common_name": "Safinamidum",
"pl_product_id": "100338983",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}See everything about safinamide.
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.