Ireland· IE-PA-EU/1/08/481/004
Kuvan 100 mg powder for oral solution
A sapropterin product containing sapropterin hydrochloride, registered in Ireland by Biomarin International Limited. The same ATC class is registered in 19 of our 19 countries.
Checked against HPRA (Ireland) 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: Ireland, from HPRA (Ireland)
- 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
HPRA (Ireland)- Active substance
- Sapropterin hydrochloride
- Manufacturer
- Biomarin International Limited
- Country
- Ireland (IE)
- ATC code
- A16AX07
- ATC class
- Sapropterin
- Defined daily dose
- 0.7 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/08/481/004
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
- BelgiumKuvan 100 mgBioMarin International
- FinlandKuvanBiomarin International Limited
- IcelandKuvanBioMarin International Limited
- PolandKuvanBioMarin International Ltd.
- SwedenKuvan 100 mg Pulver till oral lösningBioMarin International Limited
- CanadaREDDY-SAPROPTERINDR REDDY'S LABORATORIES LTD
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 HPRA (Ireland). 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/f7564c14-e502-424e-8d62-5411b0fd408d GET /v1/drugs/f7564c14-e502-424e-8d62-5411b0fd408d?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": "Powder for oral solution",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"A16AX07"
],
"strength": null,
"pa_number": "EU/1/08/481/004",
"substances": [
"Sapropterin hydrochloride"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "13/07/2017",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}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.