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Sweden· SE-20240930000235

Orvago 50 mg Filmdragerad tablett

A medicinal product containing safinamide, registered in Sweden by Elpen Pharmaceutical Co. Inc.

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedOrvago 50 mg Filmdragerad tablettATC—REGISTER NO.SE-20240930000235PACKS LISTED1CHECKEDOctober 1, 2026

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
Safinamide
Manufacturer
Elpen Pharmaceutical Co. Inc
Country
Sweden (SE)
ATC code
—
Reimbursed
Not published by this register
Source register
Swedish Medical Products Agency (Sweden)
Last checked
October 1, 2026

Packs & prices · 1

  • se_varunummer
    20240930000235

Regulatory notes

No shortage, Orange Book or US label notes for this record.

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.

All safinamide products

Authorised across Europe · EMA

The same active substance is authorised in 20 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

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 Swedish Medical Products Agency (Sweden). 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/18da7d12-b557-46d2-ab83-7a18e9340125
GET /v1/drugs/18da7d12-b557-46d2-ab83-7a18e9340125?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.

{
  "source": "lakemedelsverket",
  "doc_types": [
    "SmPC",
    "sPAR",
    "PAR",
    "PL",
    "sRMP"
  ],
  "se_npl_id": "20240930000235",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20240930000235",
  "product_doc_link": "https://docetp.mpa.se/LMF/Orvago%20film-coated%20tablet%20ENG%20SmPC_09001bee84d94718.pdf"
}

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.