Medicine passport

ORFADIN 4 mg/ml

The same active substance, strength and form as listed by each country’s medicines regulator. For showing a pharmacist abroad.

Active substance
Nitisinona
Strength
4 mg/ml
Form
suspensión oral
ATC code
A16AX04
Registered in
Spain · Swedish Orphan Biovitrum International Ab
Prescription
Prescription only
Nº Registro
104303005

Source: CIMA — Centro de Información online de Medicamentos · 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

Canada 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
ORFADIN4 mg · suspensionPrescription onlySwedish Orphan Biovitrum Ab (Publ)02469693

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/es/en/medicines/orfadin-4-mg-ml-suspension-oral