Belgium· BE-AMP-SAM339272-00
Kuvan 100 mg
A sapropterin product containing sapropterin dihydrochloride, registered in Belgium by BioMarin International. The same ATC class is registered in 19 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Sapropterin Dihydrochloride
- Manufacturer
- BioMarin International
- Country
- Belgium (BE)
- ATC code
- A16AX07
- ATC class
- Sapropterin
- Defined daily dose
- 0.7 g, O
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
1 priced- be_apb2662146EUR 1064.91
- be_apb0797522
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 KingdomKuvan 100mg soluble tabletsBioMarin (U.K.) Ltd
- SpainKUVAN 100 mg, COMPRIMIDOS SOLUBLESBiomarin International Limited
- 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.
- IrelandKuvan 100 mg soluble tabletsBiomarin International Limited
Authorised across Europe · EMA
The same active substance is authorised in 15 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
- 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 FAMHP / AFMPS (Belgium). 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/2e570bee-9f73-4ca4-9eef-ad64c4e58bd1 GET /v1/drugs/2e570bee-9f73-4ca4-9eef-ad64c4e58bd1?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": "Soluble tablet",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Kuvan 100 mg",
"name_fr": "Kuvan 100 mg",
"name_nl": "Kuvan 100 mg",
"amp_code": "SAM339272-00",
"strengths": [
"100.0000",
"77.0000"
],
"pack_count": 3,
"substances": [
"Sapropterin Dihydrochloride",
"Sapropterin",
"Mannitol",
"Sodium Stearyl Fumarate"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Sapropterin",
"authorisation_numbers": [
"EU/1/08/481/001",
"EU/1/08/481/002",
"EU/1/08/481/003"
]
}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.