Medicine passport

ORFADIN 2 mg

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

Active substance
Nitisinona
Strength
2 mg
Form
cápsula dura
ATC code
A16AX04
Registered in
Spain · Swedish Orphan Biovitrum International Ab
Prescription
Prescription only
Nº Registro
04303001

Source: CIMA — Centro de Información online de Medicamentos · 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

Canada 2 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
MDK-NITISINONE2 mg · capsulePrescription onlyMendelikabs Inc02457717
ORFADIN2 mg · capsulePrescription onlySwedish Orphan Biovitrum Ab (Publ)02459698

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

Netherlands 2 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Nitisinone Dipharma 2 mg2 mg · capsule, hardPrescription onlyDipharma Arzneimittel GmbH124830
Orfadin 2 mg2 mg · capsule, hardPrescription onlySwedish Orphan InternationalEU/1/04/303

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/es/en/medicines/orfadin-2-mg-capsula-dura