Medicine passport

Orfadin 10 mg 10 mg

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

Active substance
Nitisinon
Strength
10 mg
Form
capsule, hard
ATC code
A16AX04
Registered in
Netherlands · Swedish Orphan International
Prescription
Prescription only
RVG
EU/1/04/303

Source: Geneesmiddeleninformatiebank · 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

Bulgaria 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
TisinonТисинон10 mg · capsules, hardPrescription onlyНОБЕЛ ФАРМА ЕООД20210037

Source: Bulgarian Drug Agency register (Изпълнителна агенция по лекарствата (BDA)) · 2026-08-01

Spain 3 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
NITISINONA DIPHARMA10 mg · cápsula duraPrescription onlyDipharma Arzneimittel Gmbh83467
NITISINONE MDK10 mg · cápsula duraPrescription onlyMendelikabs Europe Limited1171217003
ORFADIN10 mg · cápsula duraPrescription onlySwedish Orphan Biovitrum International Ab04303003

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.

Canada 2 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
MDK-NITISINONE10 mg · capsulePrescription onlyMendelikabs Inc02457733
ORFADIN10 mg · capsulePrescription onlySwedish Orphan Biovitrum Ab (Publ)02459728

Source: Drug Product Database (Health Canada) · 2026-09-30 · Contains information licensed under the Open Government Licence – Canada.

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/nl/en/medicines/orfadin-10-mg-10-mg-capsule-hard