Sweden· SE-20071130000080
Kuvan 100 mg Löslig tablett
A medicinal product containing sapropterin dihydrochloride, registered in Sweden by BioMarin International Limited.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Sapropterin Dihydrochloride
- Manufacturer
- BioMarin International Limited
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20071130000080
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sapropterin dihydrochloride 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
- SpainKUVAN 100 mg, COMPRIMIDOS SOLUBLESBiomarin International Limited
- ItalyARPETRANPIAM FARMACEUTICI S.P.A.
- 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
- Spain · Sapropterina Aurovitas, Sapropterina Elc
- 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
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 Swedish Medical Products Agency (Sweden). 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/7f1b8c11-4e10-4cdd-8727-e5674e5fb65e GET /v1/drugs/7f1b8c11-4e10-4cdd-8727-e5674e5fb65e?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.
{
"source": "lakemedelsverket",
"doc_types": [
"EPAR",
"EMA"
],
"se_npl_id": "20071130000080",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20071130000080",
"product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/kuvan-epar-product-information_sv.pdf"
}See everything about sapropterin dihydrochloride.
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.