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Belgium· BE-AMP-SAM501484-00

Orfadin 4 mg/ml

A nitisinone product containing nitisinone, registered in Belgium by Swedish Orphan Biovitrum International. The same ATC class is registered in 18 of our 19 countries.

ATC A16AX04

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedOrfadin 4 mg/mlATCA16AX04REGISTER NO.BE-AMP-SAM501484-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about nitisinoneAnswers 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Nitisinone
Manufacturer
Swedish Orphan Biovitrum International
Country
Belgium (BE)
ATC code
A16AX04
ATC class
Nitisinone
Defined daily dose
20 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    7716400
  • be_apb
    3342821

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
  • 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
  • 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 FAMHP / AFMPS (Belgium). 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/76e1dcb7-c1f5-49c9-965a-d52aabf7c7b6
GET /v1/drugs/76e1dcb7-c1f5-49c9-965a-d52aabf7c7b6?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": "Oral suspension",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Orfadin 4 mg/ml",
  "name_fr": "Orfadin 4 mg/ml",
  "name_nl": "Orfadin 4 mg/ml",
  "amp_code": "SAM501484-00",
  "strengths": [
    "4.0000",
    "500.0000",
    "1.0000",
    "0.7000"
  ],
  "pack_count": 1,
  "substances": [
    "Nitisinone",
    "Glycerol",
    "Sodium Benzoate",
    "Polysorbate 80",
    "Sodium"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Nitisinone",
  "authorisation_numbers": [
    "EU/1/04/303/005"
  ]
}
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