Medicine passport

NITISINONE MDK 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
gélule
ATC code
Not stated by the register
Registered in
France · MENDELIKABS EUROPE (IRLANDE)
Prescription
Prescription only
CIS
64487446

Source: Base de données publique des médicaments · 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 5 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Nitisinone5 mg · CapsulePrescription onlyPar Health USA, LLC (+3)0254-3021
Orfadin5 mg · CapsulePrescription onlySWEDISH ORPHAN BIOVITRUM AB (PUBL)66658-105

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

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

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 2026-09-30. Mediclarum stores nothing about you for this page. https://www.mediclarum.com/fr/en/medicines/nitisinone-mdk-5-mg-gelule