Medicine passport

Orfadin 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
Not stated by the register
Registered in
United States · SWEDISH ORPHAN BIOVITRUM AB (PUBL)
Prescription
Prescription only
NDC
66658-120

Source: NDC Directory · 2026-09-13

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

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.

Canada 2 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
MDK-NITISINONE20 mg · capsulePrescription onlyMendelikabs Inc02470055
ORFADIN20 mg · capsulePrescription onlySwedish Orphan Biovitrum Ab (Publ)02459736

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 2026-09-13. Mediclarum stores nothing about you for this page. https://www.mediclarum.com/us/en/medicines/orfadin-20-mg-capsule