Spain· ES:04303003
ORFADIN 10 mg CAPSULAS DURAS
A medicinal product containing nitisinona, registered in Spain by Swedish Orphan Biovitrum International Ab.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- nitisinona
- Manufacturer
- Swedish Orphan Biovitrum International Ab
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Nitisinona 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
- FinlandNitisinone DipharmaDipharma Arzneimittel GmbH
- FranceNITISINONE DIPHARMA 10 mg, géluleDIPHARMA ARZNEIMITTEL (ALLEMAGNE)
- United KingdomNitisinone 10mg capsulesLogixx Pharma Solutions Ltd
- SwedenNitisinone Dipharma 10 mg Kapsel, hårdDipharma Arzneimittel GmbH
- NorwayNitisinone DipharmaDipharma Arzneimittel GmbH
- CanadaMDK-NITISINONEMENDELIKABS INC
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
- 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 AEMPS CIMA (Spain). 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/fed4e104-db24-40a4-a279-7a0c0dad616e GET /v1/drugs/fed4e104-db24-40a4-a279-7a0c0dad616e?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":1119909600000}",
"nregistro": "04303003",
"substance": "nitisinona"
}See everything about nitisinona.
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.