Spain· ES:08481002
KUVAN 100 mg, COMPRIMIDOS SOLUBLES
A medicinal product containing sapropterina, registered in Spain by Biomarin International Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- sapropterina
- Manufacturer
- Biomarin International Limited
- 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
Sapropterina in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomKuvan 100mg soluble tabletsBioMarin (U.K.) Ltd
- ItalyARPETRANPIAM FARMACEUTICI S.P.A.
- SwedenKuvan 100 mg Löslig tablettBioMarin International Limited
- FranceKUVAN 100 mg, comprimé pour solution buvableBIOMARIN INTERNATIONAL LIMITED (IRLANDE)
- SwitzerlandSapropterin NOBEL 100 mg, Tabletten zur Herstellung einer Lösung zum EinnehmenNOBEL Pharma Schweiz AG
- PolandKuvanBioMarin International Ltd.
- BelgiumKuvan 100 mgBioMarin International
- IrelandKuvan 100 mg soluble tabletsBiomarin International Limited
Authorised across Europe · EMA
The same active substance is authorised in 14 EEA countries. Names it is sold under:
- Bulgaria · Сапроптерин Тева
- Czechia · Sapropterin Piam Farmaceutici
- Germany · Arpetran, Sapropterin Al
- Denmark · Arpetran, Sapropterin Sandoz
- France · Sapropterine Arrow, Sapropterine Teva
- United Kingdom (Northern Ireland) · Sapropterin Dihydrochloride, Sapropterin Dihydrochloride Amarox
- Iceland · Kuvan, Sapropterin Dipharma
- Italy · Arpetran, Sapropterina Aurobindo
- Liechtenstein · Kuvan, Sapropterin Dipharma
- Malta · Sapropterina Generis
- Netherlands · Arpetran, Sapropterin Aurobindo
- Norway · Kuvan, Sapropterin Dipharma
- Portugal · Arpetran, Sapropterina Generis
- Sweden · Sapropterin Stada, Sapropterin Teva
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/98c5edd2-8a09-465b-b273-733b79ec4183 GET /v1/drugs/98c5edd2-8a09-465b-b273-733b79ec4183?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\":1232319600000}",
"nregistro": "08481002",
"substance": "sapropterina"
}See everything about sapropterina.
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.