Drug Database
Back to search

Italy· 038922023

KUVAN

A sapropterin product containing sapropterina, registered in Italy by BIOMARIN INTERNATIONAL LIMITED, on the national reimbursement list. The same ATC class is registered in 19 of our 19 countries.

Reimbursed in Italy (AIFA class A)ATC A16AX07

Checked against AIFA (Italy) on

Informational only — not a medical device.

SOURCE REGISTER · ITAIFA (Italy)normalisedKUVANATCA16AX07REGISTER NO.038922023PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about sapropterinaAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Italy, from AIFA (Italy)
  • 11 of them publish a price we can compare per daily dose
Search sapropterin products by name

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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.

  • Italy: $156.69 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Sapropterin · price per daily dose (0.7 g)

USD · FX 28 Sept 2026

  • CH Switzerland$159.61
  • IT Italy$156.69
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

AIFA (Italy)
Active substance
Sapropterina
Manufacturer
BIOMARIN INTERNATIONAL LIMITED
Country
Italy (IT)
ATC code
A16AX07
ATC class
Sapropterin
Defined daily dose
0.7 g, O
Reimbursed
Yes
Source register
AIFA (Italy)
Last checked
September 28, 2026

Packs & prices · 1

  • aic
    038922023
    100 MG - COMPRESSA SOLUBILE - USO ORALE - FLACONE (HDPE) 120 COMPRESSE

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
Check sapropterin against other medicinesHow interaction checks work

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All sapropterin products

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
  • 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 AIFA (Italy). 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/ad56423d-bf01-4855-9628-725941e4a31c
GET /v1/drugs/ad56423d-bf01-4855-9628-725941e4a31c?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.

{
  "pack": "100 MG - COMPRESSA SOLUBILE - USO ORALE  - FLACONE (HDPE) 120 COMPRESSE",
  "source": "aifa",
  "currency": "EUR",
  "substance": "Sapropterina",
  "reference_pack": "120 UNITA' 100 MG - USO ORALE",
  "public_price_eur": null,
  "ssn_reference_price_eur": null
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console