Medicine passport

Nitisinone 5 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
5 mg
Form
Capsule
ATC code
Not stated by the register
Registered in
United States · Bryant Ranch Prepack
Prescription
Prescription only
NDC
63629-2235

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

Bulgaria 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
TisinonТисинон5 mg · capsules, hardPrescription onlyНОБЕЛ ФАРМА ЕООД20210036

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

France 3 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
NITISINONE DIPHARMA5 mg · gélulePrescription onlyDIPHARMA ARZNEIMITTEL (ALLEMAGNE)62524376
NITISINONE MDK5 mg · gélulePrescription onlyMENDELIKABS EUROPE (IRLANDE)64487446
ORFADIN5 mg · gélulePrescription onlySWEDISH ORPHAN BIOVITRUM INTERNATIONAL (SUEDE)60459499

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-NITISINONE5 mg · capsulePrescription onlyMendelikabs Inc02457725
ORFADIN5 mg · capsulePrescription onlySwedish Orphan Biovitrum Ab (Publ)02459701

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/nitisinone-5-mg-capsule-bryant-ranch-prepack