ORFADIN 5 mg
The same active substance, strength and form as listed by each country’s medicines regulator. For showing a pharmacist abroad.
- Active substance
- Nitisinona
- Strength
- 5 mg
- Form
- cápsula dura
- ATC code
- A16AX04
- Registered in
- Spain · Swedish Orphan Biovitrum International Ab
- Prescription
- Prescription only
- Nº Registro
- 04303002
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
Bulgaria 1 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| TisinonТисинон | 5 mg · capsules, hard | Prescription only | НОБЕЛ ФАРМА ЕООД | 20210036 |
Source: Bulgarian Drug Agency register (Изпълнителна агенция по лекарствата (BDA)) · 2026-08-01
Canada 2 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| MDK-NITISINONE | 5 mg · capsule | Prescription only | Mendelikabs Inc | 02457725 |
| ORFADIN | 5 mg · capsule | Prescription only | Swedish Orphan Biovitrum Ab (Publ) | 02459701 |
Source: Drug Product Database (Health Canada) · 2026-09-30 · Contains information licensed under the Open Government Licence – Canada.
Netherlands 2 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| Nitisinone Dipharma 5 mg | 5 mg · capsule, hard | Prescription only | Dipharma Arzneimittel GmbH | 123246 |
| Orfadin 5 mg | 5 mg · capsule, hard | Prescription only | Swedish Orphan International | EU/1/04/303 |
Source: Geneesmiddeleninformatiebank (College ter Beoordeling van Geneesmiddelen (CBG-MEB)) · 2026-09-30 · Bron: College ter Beoordeling van Geneesmiddelen (CBG). De Rijksoverheid is het niet automatisch eens met de inhoud van deze site.
Same active substance, but no match for this strength and form
- European Union: 3 products · Every strength and form
- Switzerland: 4 products · Every strength and form