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Netherlands· NL-1949537b4513

Orfadin 20 mg, harde capsules

A nitisinone product containing nitisinon, registered in Netherlands by Swedish Orphan Biovitrum AB (publ). The same ATC class is registered in 18 of our 19 countries.

ATC A16AX04

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedOrfadin 20 mg, harde capsulesATCA16AX04REGISTER NO.NL-1949537b4513PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about nitisinonAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Nitisinone is registered in 18 of 19 countries.

Countries holding a registration under ATC A16AX04 (nitisinone), each read from that country’s own register.

  • This record: Netherlands, from CBG-MEB (Netherlands)
  • 10 of them publish a price we can compare per daily dose
Search nitisinone products by name

Nitisinone · ATC A16AX04

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
NITISINON
Manufacturer
Swedish Orphan Biovitrum AB (publ)
Country
Netherlands (NL)
ATC code
A16AX04
ATC class
Nitisinone
Defined daily dose
20 mg, O
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/04/303

Regulatory notes

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

Interactions

235 interactions on record for nitisinone.

Graded by severity as the source publishes them — 2 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
Check nitisinone against other medicinesHow interaction checks work

Nitisinone · interactions on record

235 records

  • 2 severe
  • 231 moderate
  • 2 minor

Most severe, free to view

  • ClotrimazoleA01AB18moderate
  • CimetidineA02BA01moderate
  • DronabinolA04AD10moderate
  • AprepitantA04AD12moderate
  • 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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All nitisinone products

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
  • Norway · Nitisinone Dipharma, Orfadin
  • Portugal · Nitisinona Dipharma
  • Sweden · Nitisinone 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 CBG-MEB (Netherlands). 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/f9de6a86-6053-4b8c-8818-4bc8f6343428
GET /v1/drugs/f9de6a86-6053-4b8c-8818-4bc8f6343428?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": "Capsule, hard",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/orfadin-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Nitisinone",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp115246",
  "excipients": [
    "AMMONIA (E 527)",
    "GELATINE (E 441)",
    "IJZEROXIDE ZWART (E 172)",
    "MAÏSZETMEEL, GEPREGELATINEERD",
    "PROPYLEENGLYCOL (E 1520)",
    "SCHELLAK (E 904)",
    "TITAANDIOXIDE (E 171)",
    "ZWARTE INKT"
  ],
  "substances": [
    "NITISINON"
  ],
  "leaflet_url": null,
  "authorised_at": "2015/05/05",
  "procedure_number": "EMEA/H/C/000555",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/04/303",
  "additional_monitoring": "N"
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console