In other countries
The same active substances on other registers, the same brand first.
- OrfadinArgentina · 10 MG, 20 MG, 5 MG · cápsula dura · Daxley Argentina S.A.Same form
- MDK-NitisinoneCanada · 5 MG · Capsule · Mendelikabs INCSame form
- MDK-NitisinoneCanada · 10 MG · Capsule · Mendelikabs INCSame form
- MDK-NitisinoneCanada · 2 MG · Capsule · Mendelikabs INCSame form
- Nitisinona Dipharma 10 MG Capsulas Duras EfgSpain · 10 mg · cápsula dura · Dipharma Arzneimittel GmbhSame form
- Nitisinona Dipharma 2 MG Capsulas Duras EfgSpain · 2 mg · cápsula dura · Dipharma Arzneimittel GmbhSame form
- Nitisinona Dipharma 20 MG Capsulas Duras EfgSpain · 20 mg · cápsula dura · Dipharma Arzneimittel GmbhSame form
- Nitisinone DipharmaItaly · Capsula rigida · Dipharma Arzneimittel GmbHSame form
- OrfadinItaly · Capsula rigida · Swedish Orphan Biovitrum International ABSame form
- Nitisinone LogixX PharmaNew Zealand · Cap 10 mgSame form
- Nitisinone LogixX PharmaNew Zealand · Cap 2 mgSame form
- Nitisinone LogixX PharmaNew Zealand · Cap 5 mgSame form
- NITISINONE MENDELIKABS 10 mgRomania · 10 mg · caps. · Mendelikabs Europe LimitedSame form
- NITISINONE MENDELIKABS 2 mgRomania · 2 mg · caps. · Mendelikabs Europe LimitedSame form
- NITISINONE MENDELIKABS 5 mgRomania · 5 mg · caps. · Mendelikabs Europe LimitedSame form
- Orfadin 10 MG CapsuleSaudi Arabia · Apotek Produktion & Laboratorier ABSame form
- Orfadin 2 MG CapsuleSaudi Arabia · Apotek Produktion & Laboratorier ABSame form
- Orfadin 20 MG CapsuleSaudi Arabia · Apotek Produktion & Laboratorier ABSame form
- NitisinoneUnited States · 10MG, 20MG, 2MG … · capsule · EtonSame form
- OrfadinUnited States · 10MG, 20MG, 2MG … · capsule · Swedish OrphanSame form
- NitikabsBrazil · Pharmedic Pharmaceuticals, Importacao, Exportacao, Distribuicao, Comercio e Representacoes LtdaSame substance
- OrfadinBrazil · Innovative Medicines Brasil SP Distribuicao de Medicamentos LtdaSame substance
- OrfadinBrazil · Innovative Medicines Brasil SP Distribuicao de Medicamentos LtdaSame substance
- NityrEuropean Union · Cycle Pharmaceuticals (Europe) LtdSame substance
- OrfadinEuropean Union · Swedish Orphan Biovitrum International ABSame substance
- Nitisinone MDK (previously Nitisinone MendeliKABS)European Union · MendeliKABS Europe LtdSame substance
- NityrCroatiaSame substance
- OrfadinCroatiaSame substance
- HarlikuUnited States · 2MG · tablet · CycleSame substance
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.
Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Nitisinone
- Dosage form
- Capsule, hard
- Route
- Oraal gebruik
- Register
- Netherlands (CBG-MEB)
- Status
- Authorised
- Status in the register
- Ingeschreven
- Authorised
- 29 Apr 2020
- Registration
- 124830
- Marketing authorisation holder
- Dipharma Arzneimittel GmbH
- ATC code
- A16AX04
- Procedure
- National (RVG)
- Supply
- Uitsluitend recept