Medicine passport

NITISINONE DIPHARMA 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
gélule
ATC code
Not stated by the register
Registered in
France · DIPHARMA ARZNEIMITTEL (ALLEMAGNE)
Prescription
Prescription only
CIS
66595463

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
Nitisinone10 mg · CapsulePrescription onlyPar Health USA, LLC (+3)0254-3022
Orfadin10 mg · CapsulePrescription onlySWEDISH ORPHAN BIOVITRUM AB (PUBL)66658-110

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
TisinonТисинон10 mg · capsules, hardPrescription onlyНОБЕЛ ФАРМА ЕООД20210037

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-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 2026-09-30. Mediclarum stores nothing about you for this page. https://www.mediclarum.com/fr/en/medicines/nitisinone-dipharma-10-mg-gelule