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
Nitisinone
Strength
4 mg/mL
Form
Suspension
ATC code
Not stated by the register
Registered in
United States · Swedish Orphan Biovitrum AB (publ)
Prescription
Prescription only
NDC
66658-204

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

France 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
ORFADIN4 mg · suspension buvablePrescription onlySWEDISH ORPHAN BIOVITRUM INTERNATIONAL (SUEDE)66880925

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 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 2026-09-13. Mediclarum stores nothing about you for this page. https://www.mediclarum.com/us/en/medicines/orfadin-4-mg-ml-suspension