Sweden· SE-20040607003558
Orfadin 10 mg Kapsel, hård
A medicinal product containing nitisinone, registered in Sweden by Swedish Orphan Biovitrum International AB.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Nitisinone
- Manufacturer
- Swedish Orphan Biovitrum International AB
- 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_varunummer20040607003558
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Nitisinone in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesNitisinoneBryant Ranch Prepack
- BelgiumNitisinone Dipharma 10 mgDipharma Arzneimittel
- SpainNITISINONA DIPHARMA 10 MG CAPSULAS DURAS EFGDipharma Arzneimittel Gmbh
- FinlandNitisinone DipharmaDipharma Arzneimittel GmbH
- FranceNITISINONE DIPHARMA 10 mg, géluleDIPHARMA ARZNEIMITTEL (ALLEMAGNE)
- United KingdomNitisinone 10mg capsulesLogixx Pharma Solutions Ltd
- CanadaMDK-NITISINONEMENDELIKABS INC
- ItalyNITISINONE DIPHARMADIPHARMA ARZNEIMITTEL GMBH
Authorised across Europe · EMA
The same active substance is authorised in 17 EEA countries. Names it is sold under:
- Austria · Nitisinon Dipharma
- Belgium · Nitisinone Dipharma
- Bulgaria · Тисинон
- Germany · Nitisinone Dipharma
- Denmark · Nitisinone Dipharma
- Spain · Nitisinona Dipharma
- Finland · Nitisinone Dipharma
- France · Nitisinone Dipharma
- United Kingdom (Northern Ireland) · Nitisinone Logixx Pharma
- Ireland · Nitisinone Dipharma
- Iceland · Orfadin
- Italy · Nitisinone Dipharma
- Liechtenstein · Orfadin
- Netherlands · Nitisinone Dipharma
- Norway · Nitisinone Dipharma, Orfadin
- Portugal · Nitisinona Dipharma
- Slovakia · Nitisinone Dipharma
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/b8c39164-2a9c-4927-b08d-7bfe817135c2 GET /v1/drugs/b8c39164-2a9c-4927-b08d-7bfe817135c2?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": [
"EMA",
"EPAR"
],
"se_npl_id": "20040607003558",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20040607003558",
"product_doc_link": "https://www.ema.europa.eu/en/medicines/human/EPAR/orfadin"
}See everything about nitisinone.
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.