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Sweden· SE-20160310000085

Xtandi 80 mg Filmdragerad tablett

A medicinal product containing enzalutamide, registered in Sweden by Astellas Pharma Europe BV.

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedXtandi 80 mg Filmdragerad tablettATC—REGISTER NO.SE-20160310000085PACKS LISTED1CHECKEDOctober 1, 2026

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
Enzalutamide
Manufacturer
Astellas Pharma Europe BV
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
    20160310000085

Regulatory notes

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

Same medicine, other countries

Enzalutamide in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All enzalutamide products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Englabloc, Enzalutamid 1a Pharma
  • Belgium · Enzalutamide Accord, Enzalutamide Eg
  • Bulgaria · Ензалутамид Sdz, Ензалутамид Сандоз
  • Cyprus · Enzalutamide Accord, Enzalutamide Ebewe
  • Czechia · Enzalutamid Sandoz S.R.O., Enzalutamid Stada
  • Germany · Enzalutamid Accord, Enzalutamid Al
  • Denmark · Enzalutamide "sandoz", Enzalutamide Hexal
  • Estonia · Enzalutamide Accord, Enzalutamide Norameda
  • Spain · Enzalutamida Accord, Enzalutamida Sandoz
  • Finland · Enzalutamide 1a Farma, Enzalutamide Adalvo
  • France · Enzalutamide Accord, Enzalutamide Biogaran
  • United Kingdom (Northern Ireland) · Enzalutamide Accord Healthcare, Enzalutamide Genus Pharmaceuticals
  • Greece · Enzalutamide Accord, Enzalutamide Anabiosis
  • Croatia · Enzalutamid Accord, Enzalutamid Pharmascience
  • Hungary · Enzalutamid 1 A Pharma, Enzalutamid Sandoz
  • Ireland · Enzalutamide Accord, Enzalutamide Clonmel
  • Iceland · Enzalutamide Accordpharma, Enzalutamide Hexal
  • Italy · Enzalutamide Accord, Enzalutamide Eg
  • Liechtenstein · Enzalutamide Accordpharma, Enzalutamide Viatris
  • Lithuania · Enzalutamide Accord, Enzalutamide Hexal
  • Luxembourg · Enzalutamide Eg
  • Latvia · Enzalutamide Accord, Enzalutamide Hexal
  • Malta · Enzalutamid Pharos, Enzalutamide
  • Netherlands · Enzalutamide 1a Pharma, Enzalutamide Anabiosis
  • Norway · Enzalutamide Accord, Enzalutamide Accordpharma
  • Poland · Enzalutamid Sandoz, Enzalutamide
  • Portugal · Enzalutamida Stada, Enzalutamida Stada 40 Mg Comprimidos Revestidos Por Película
  • Romania · Enzalutamidă Accord, Enzalutamida Rhei
  • Slovenia · Enzalutamid Sandoz, Enzalutamid Sandoz Gmbh
  • Slovakia · Englabloc, Enzalutamid Sandoz

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/f08b7a2d-3890-4062-bca6-42d7fcc36d94
GET /v1/drugs/f08b7a2d-3890-4062-bca6-42d7fcc36d94?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": [
    "EPAR",
    "EMA"
  ],
  "se_npl_id": "20160310000085",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20160310000085",
  "product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/xtandi-epar-product-information_sv.pdf"
}

See everything about enzalutamide.

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.