Spain· ES:104303005
ORFADIN 4 mg/ml SUSPENSION ORAL
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.
- BelgiumOrfadin 4 mg/mlSwedish Orphan Biovitrum International
- CzechiaORFADINSwedish Orphan Biovitrum International AB, Stockholm
- FinlandOrfadinSwedish Orphan Biovitrum AB (publ)
- FranceORFADIN 4 mg/ml, suspension buvableSWEDISH ORPHAN BIOVITRUM INTERNATIONAL (SUEDE)
- IrelandOrfadin 4 mg/ml oral suspensionSwedish Orphan Biovitrum AB
- IcelandOrfadin*Swedish Orphan Biovitrum International AB
- NetherlandsOrfadin 4 mg/ml, suspensie voor oraal gebruikSwedish Orphan Biovitrum AB (publ)
- NorwayOrfadinSwedish Orphan Biovitrum International AB
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/efa1d2fc-e28c-4afb-a3fe-567a1772d224 GET /v1/drugs/efa1d2fc-e28c-4afb-a3fe-567a1772d224?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\":1437948000000}",
"nregistro": "104303005",
"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.