Netherlands· NL-2261e64b362f
Kuvan 100 mg oplosbare tabletten
A sapropterin product containing sapropterinedihydrochloride, registered in Netherlands by BioMarin International Limited. The same ATC class is registered in 19 of our 19 countries.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
Where it is registered
Sapropterin is registered in 19 of 19 countries.
Countries holding a registration under ATC A16AX07 (sapropterin), each read from that country’s own register.
- This record: Netherlands, from CBG-MEB (Netherlands)
- 11 of them publish a price we can compare per daily dose
Sapropterin · ATC A16AX07
19 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of sapropterin costs, country by country.
Normalised to the WHO defined daily dose (0.7 g), so markets compare like for like.
- 2 markets with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Sapropterin · price per daily dose (0.7 g)
USD · FX 28 Sept 2026
- CH Switzerland$159.61
- IT Italy$156.69
The record
At a glance
CBG-MEB (Netherlands)- Active substance
- SAPROPTERINEDIHYDROCHLORIDE
- Manufacturer
- BioMarin International Limited
- Country
- Netherlands (NL)
- ATC code
- A16AX07
- ATC class
- Sapropterin
- Defined daily dose
- 0.7 g, O
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_idEU/1/08/481
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
29 interactions on record for sapropterin.
Graded by severity as the source publishes them — 29 moderate. 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
Sapropterin · interactions on record
29 records
- 29 moderate
Most severe, free to view
- Glyceryl trinitrateC01DA02moderate
- Isosorbide dinitrateC01DA08moderate
- Isosorbide mononitrateC01DA14moderate
- NesiritideC01DX19moderate
- 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
Sapropterin in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesJAVYGTORDr. Reddys Laboratories Inc
- CzechiaKUVANBioMarin International Limited, Dublin
- SwitzerlandKuvan
- IcelandKuvanBioMarin International Limited
- NorwaySapropterin DipharmaDipharma Arzneimittel GmbH
- FinlandKuvanBiomarin International Limited
- CanadaKUVANBIOMARIN INTERNATIONAL LIMITED
- United KingdomKuvan 100mg soluble tabletsBioMarin (U.K.) Ltd
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
- 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 CBG-MEB (Netherlands). 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/f68cf16d-38f3-499c-b4bb-be8df45f09e9 GET /v1/drugs/f68cf16d-38f3-499c-b4bb-be8df45f09e9?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": "Tablet",
"route": "Oraal gebruik",
"soort": null,
"source": "cbg_meb",
"smpc_url": "https://www.ema.europa.eu/en/documents/product-information/kuvan-epar-product-information_nl.pdf",
"strength": null,
"atc_label": "Sapropterin",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp101534",
"excipients": [
"ASCORBINEZUUR (E 300)",
"CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341)",
"CROSPOVIDON (E 1202)",
"MANNITOL (D-) (E 421)",
"NATRIUMSTEARYLFUMARAAT",
"RIBOFLAVINE (E 101)"
],
"substances": [
"SAPROPTERINEDIHYDROCHLORIDE"
],
"leaflet_url": null,
"authorised_at": "2008/12/02",
"procedure_number": "EMEA/H/C/000943",
"dispensing_status": "Uitsluitend recept",
"registration_number": "EU/1/08/481",
"additional_monitoring": "N"
}See everything about sapropterin.
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.