IE
IE · IE · IE-PA-EU/1/08/481/005
Kuvan 500 mg powder for oral solution
ATC A16AX07
Last synced from HPRA (Ireland) on
Identification
ManufacturerBioMarin International Limited
CountryIE (IE)
ATC codeA16AX07
Dispensing—
ReimbursedNo
SourceHPRA (Ireland)
Last synced6/8/2026
Packs · 1
- ie_pa_numberEU/1/08/481/005
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Raw payload (JSON)
{
"form": "Powder for oral solution",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"A16AX07"
],
"strength": null,
"pa_number": "EU/1/08/481/005",
"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
}Related drugs
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