Medicine passport

ALOG-SAPROPTERIN 100 mg

The same active substance, strength and form as listed by each country’s medicines regulator. For showing a pharmacist abroad.

Active substance
Sapropterin Dihydrochloride
Strength
100 mg
Form
tablet
ATC code
A16AX07
Registered in
Canada · Analog Pharma Canada Inc.
Prescription
Prescription only
DIN
02547481

Source: Drug Product Database · 2026-09-30

Not a prescription. Not a statement that these products are interchangeable. Products are matched on active substance, strength and kind of form only. Other ingredients, release, approved uses and the dose on the box can differ. A pharmacist or doctor decides whether one can replace another.

Listed in other countries

United States 7 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Sapropterin Dihydrochloride100 mg · TabletPrescription onlyHikma Pharmaceuticals USA Inc. (+4)0054-0906
Javygtor100 mg · TabletPrescription onlyDr. Reddys Laboratories Inc43598-096
Kuvan100 mg · TabletPrescription onlyBioMarin Pharmaceutical Inc.68135-300

Source: NDC Directory (US Food and Drug Administration) · 2026-09-13 · Source: US Food and Drug Administration, NDC Directory.

Spain 7 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
KUVAN100 mg · comprimidoPrescription onlyBiomarin International Limited08481002
SAPROPTERINA AUROVITAS100 mg · comprimido solublePrescription onlyAurovitas Spain, S.A.U.88742
SAPROPTERINA DIPHARMA100 MG · comprimido solublePrescription onlyDipharma Arzneimittel Gmbh1211620001
SAPROPTERINA ELC100 mg · comprimido solublePrescription onlyElc Group S.R.O.91529
SAPROPTERINA STADA100 mg · comprimido solublePrescription onlyLaboratorio Stada S.L.89442
SAPROPTERINA TARBIS100 mg · comprimido solublePrescription onlyTarbis Farma S.L.89850

1 more names not shown. Source: CIMA — Centro de Información online de Medicamentos (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)) · 2026-09-30 · Fuente: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), CIMA.

Netherlands 8 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Arpetran 100 mg oplosbare tabletten100 mg · oplosbare tabletPrescription onlyPIAM Farmaceutici S.p.A.127858
Kuvan 100 mg oplosbare tabletten100 mg · tabletPrescription onlyBioMarin International LimitedEU/1/08/481
Sapropterin Dipharma 100 mg100 mg · oplosbare tabletPrescription onlyDipharma Arzneimittel GmbHEU/1/21/1620
Sapropterine Amarox 100 mg oplosbare tabletten100 mg · oplosbare tabletPrescription onlyAmarox Pharma B.V.130083
Sapropterine Aurobindo 100 mg100 mg · oplosbare tabletPrescription onlyAurobindo Pharma B.V.129516
Sapropterine diHCl CF 100 mg100 mg · oplosbare tabletPrescription onlyCentrafarm B.V.130481

2 more names not shown. Source: Geneesmiddeleninformatiebank (College ter Beoordeling van Geneesmiddelen (CBG-MEB)) · 2026-09-30 · Bron: College ter Beoordeling van Geneesmiddelen (CBG). De Rijksoverheid is het niet automatisch eens met de inhoud van deze site.

Same active substance, but no match for this strength and form

Countries covered: United States, Bulgaria, European Union, Spain, France, Netherlands, Canada, Switzerland. A country missing from the list may still sell this medicine: Mediclarum reads only these registers.

Register data as of 2026-09-30. Mediclarum stores nothing about you for this page. https://www.mediclarum.com/ca/en/medicines/alog-sapropterin-100-mg-tablet