Ireland· IE-PA-PA23449/001/004
Nitisinone Dipharma 20 mg hard capsules
A nitisinone product containing nitisinone, registered in Ireland by Dipharma Arzneimittel GmbH. The same ATC class is registered in 18 of our 19 countries.
Checked against HPRA (Ireland) 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: Ireland, from HPRA (Ireland)
- 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
HPRA (Ireland)- Active substance
- Nitisinone
- Manufacturer
- Dipharma Arzneimittel GmbH
- Country
- Ireland (IE)
- ATC code
- A16AX04
- ATC class
- Nitisinone
- Defined daily dose
- 20 mg, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA23449/001/004
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 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.
- BelgiumNitisinone Dipharma 20 mgDipharma Arzneimittel
- FinlandNitisinone DipharmaDipharma Arzneimittel GmbH
- SwedenNitisinone Dipharma 20 mg Kapsel, hårdDipharma Arzneimittel GmbH
- United StatesNitisinoneEton Pharmaceuticals, Inc.
- SpainNITISINONA DIPHARMA 20 MG CAPSULAS DURAS EFGDipharma Arzneimittel Gmbh
- FranceNITISINONE DIPHARMA 20 mg, géluleDIPHARMA ARZNEIMITTEL (ALLEMAGNE)
- United KingdomNitisinone 20mg capsulesLogixx Pharma Solutions Ltd
- 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
- 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 HPRA (Ireland). 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/9e5825d8-0c9a-4ab8-be36-6a75995f83af GET /v1/drugs/9e5825d8-0c9a-4ab8-be36-6a75995f83af?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",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"A16AX04"
],
"strength": null,
"pa_number": "PA23449/001/004",
"substances": [
"Nitisinone"
],
"legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "01/05/2020",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}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.