Denmark· DK-28103092399
Orfadin
A nitisinone product containing nitisinon, registered in Denmark by Swedish Orphan Biovitrum Interna. The same ATC class is registered in 18 of our 19 countries.
Checked against Danish Medicines Agency (Denmark) on
Informational only — not a medical device.
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: Denmark, from Danish Medicines Agency (Denmark)
- 10 of them publish a price we can compare per daily dose
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
The record
At a glance
Danish Medicines Agency (Denmark)- Active substance
- NITISINON
- Manufacturer
- Swedish Orphan Biovitrum Interna
- Country
- Denmark (DK)
- ATC code
- A16AX04
- ATC class
- Nitisinone
- Defined daily dose
- 20 mg, O
- Reimbursed
- Not published by this register
- Source register
- Danish Medicines Agency (Denmark)
- Last checked
- September 30, 2026
Packs & prices · 1
- dk_varenummer28103092399
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
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.
Same class
Other records under A16AX04
Nitisinone, as other registers publish it.
- United StatesHARLIKUCycle Pharmaceuticals Ltd.
- CanadaMDK-NITISINONEMENDELIKABS INC
- CanadaMDK-NITISINONEMENDELIKABS INC
- CanadaMDK-NITISINONEMENDELIKABS INC
- SwitzerlandNitisinon NOBEL 10 mg, HartkapselnNOBEL Pharma Schweiz AG
- SwitzerlandNitisinon NOBEL 20 mg, HartkapselnNOBEL Pharma Schweiz AG
- SwitzerlandNitisinon NOBEL 4 mg/ml, SuspensionNOBEL Pharma Schweiz AG
- SwitzerlandNitisinon NOBEL 5 mg, HartkapselnNOBEL Pharma Schweiz AG
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of Danish Medicines Agency (Denmark). 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/a8575279-882e-4b3c-9554-b43ca73f7cd6 GET /v1/drugs/a8575279-882e-4b3c-9554-b43ca73f7cd6?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": "kapsler, hårde",
"source": "dkma",
"strength": "2 mg",
"auth_role": "CO-RAP",
"dk_drugid": "28103092399",
"substance": "NITISINON",
"auth_procedure": "Central",
"in_medicinpriser": true,
"registration_date_serial": "38404"
}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.