Medicine passport

Nitisinone 10 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
10 mg
Form
Capsule
ATC code
Not stated by the register
Registered in
United States · Bryant Ranch Prepack
Prescription
Prescription only
NDC
63629-2233

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
TisinonТисинон10 mg · capsules, hardPrescription onlyНОБЕЛ ФАРМА ЕООД20210037

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 DIPHARMA10 mg · gélulePrescription onlyDIPHARMA ARZNEIMITTEL (ALLEMAGNE)66595463
NITISINONE MDK10 mg · gélulePrescription onlyMENDELIKABS EUROPE (IRLANDE)63259799
ORFADIN10 mg · gélulePrescription onlySWEDISH ORPHAN BIOVITRUM INTERNATIONAL (SUEDE)64147632

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-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 2026-09-13. Mediclarum stores nothing about you for this page. https://www.mediclarum.com/us/en/medicines/nitisinone-10-mg-capsule-bryant-ranch-prepack