Medicine passport

MDK-NITISINONE 20 mg

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

Active substance
Nitisinone
Strength
20 mg
Form
capsule
ATC code
A16AX04
Registered in
Canada · Mendelikabs Inc
Prescription
Prescription only
DIN
02470055

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 3 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Nitisinone20 mg · CapsulePrescription onlyAnalog Pharma (+1)70505-220
Orfadin20 mg · CapsulePrescription onlySWEDISH ORPHAN BIOVITRUM AB (PUBL)66658-120

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

Spain 2 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
NITISINONA DIPHARMA20 mg · cápsula duraPrescription onlyDipharma Arzneimittel Gmbh85155
ORFADIN20 mg · cápsula duraPrescription onlySwedish Orphan Biovitrum International Ab104303004

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.

France 2 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
NITISINONE DIPHARMA20 mg · gélulePrescription onlyDIPHARMA ARZNEIMITTEL (ALLEMAGNE)60069307
ORFADIN20 mg · gélulePrescription onlySWEDISH ORPHAN BIOVITRUM INTERNATIONAL (SUEDE)64861673

Source: Base de données publique des médicaments (ANSM / Ministère de la Santé) · 2026-09-30 · Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte.

Netherlands 2 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Nitisinone Dipharma 20 mg20 mg · capsule, hardPrescription onlyDipharma Arzneimittel GmbH124831
Orfadin 20 mg20 mg · capsule, hardPrescription onlySwedish Orphan Biovitrum AB (publ)EU/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/ca/en/medicines/mdk-nitisinone-20-mg-capsule