ORFADIN 4 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
- 4 mg
- Form
- suspension
- ATC code
- A16AX04
- Registered in
- Canada · Swedish Orphan Biovitrum Ab (Publ)
- Prescription
- Prescription only
- DIN
- 02469693
Source: Drug Product Database · 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 1 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| Orfadin | 4 mg/mL · Suspension | Prescription only | Swedish Orphan Biovitrum AB (publ) | 66658-204 |
Source: NDC Directory (US Food and Drug Administration) · 2026-09-13 · Source: US Food and Drug Administration, NDC Directory.
Spain 1 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| ORFADIN | 4 mg/ml · suspensión oral | Prescription only | Swedish Orphan Biovitrum International Ab | 104303005 |
Source: CIMA — Centro de Información online de Medicamentos (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)) · 2026-09-30 · Fuente: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), CIMA.
France 1 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| ORFADIN | 4 mg · suspension buvable | Prescription only | SWEDISH 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.
Same active substance, but no match for this strength and form
- Bulgaria: 2 products · Every strength and form
- European Union: 3 products · Every strength and form
- Netherlands: 10 products · Every strength and form
- Switzerland: 4 products · Every strength and form