Tisinon 5 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
- 5 mg
- Form
- capsules, hard
- ATC code
- A16AX04
- Registered in
- Bulgaria · НОБЕЛ ФАРМА ЕООД
- Prescription
- Prescription only
- Reg. no.
- 20210036
Source: Bulgarian Drug Agency register · 2026-08-01
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 box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| Nitisinone | 5 mg · Capsule | Prescription only | Par Health USA, LLC (+3) | 0254-3021 |
| Orfadin | 5 mg · Capsule | Prescription only | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 66658-105 |
Source: NDC Directory (US Food and Drug Administration) · 2026-09-13 · Source: US Food and Drug Administration, NDC Directory.
Spain 3 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| NITISINONA DIPHARMA | 5 mg · cápsula dura | Prescription only | Dipharma Arzneimittel Gmbh | 83468 |
| NITISINONE MDK | 5 mg · cápsula dura | Prescription only | Mendelikabs Europe Limited | 1171217002 |
| ORFADIN | 5 mg · cápsula dura | Prescription only | Swedish Orphan Biovitrum International Ab | 04303002 |
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 3 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| NITISINONE DIPHARMA | 5 mg · gélule | Prescription only | DIPHARMA ARZNEIMITTEL (ALLEMAGNE) | 62524376 |
| NITISINONE MDK | 5 mg · gélule | Prescription only | MENDELIKABS EUROPE (IRLANDE) | 64487446 |
| ORFADIN | 5 mg · gélule | Prescription only | SWEDISH ORPHAN BIOVITRUM INTERNATIONAL (SUEDE) | 60459499 |
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 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