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Medicines
Spain
Nitisinone

AEMPS 2015

Nitisinone

ORFADIN 4 mg/ml SUSPENSION ORAL

4,0 mg suspensión oralSpainMarketedAuthorised 26 Jul 2015

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

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 brand
OrfadinBrazil · Innovative Medicines Brasil SP Distribuicao de Medicamentos LtdaSame brand
OrfadinBrazil · Innovative Medicines Brasil SP Distribuicao de Medicamentos LtdaSame brand
OrfadinCanada · 4 MG / ML · Suspension · Swedish Orphan Biovitrum AB (Publ)Same brand
OrfadinCanada · 10 MG · Capsule · Swedish Orphan Biovitrum AB (Publ)Same brand
OrfadinCanada · 5 MG · Capsule · Swedish Orphan Biovitrum AB (Publ)Same brand
OrfadinEuropean Union · Swedish Orphan Biovitrum International ABSame brand

More with the same substance on this register

Nitisinona Dipharma 10 MG Capsulas Duras EfgNitisinone · 10 mg · cápsula duraSpain
Nitisinona Dipharma 2 MG Capsulas Duras EfgNitisinone · 2 mg · cápsula duraSpain

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

OrfadinCroatia

Same brand

🇮🇹OrfadinItaly · Capsula rigida · Swedish Orphan Biovitrum International ABSame brand

🇳🇱Orfadin 4 mg/ml, suspensie voor oraal gebruikNetherlands · Suspensie voor oraal gebruik · Swedish Orphan Biovitrum AB (publ)Same brand

🇳🇱Orfadin 10 mg, harde capsulesNetherlands · Capsule, hard · Swedish Orphan InternationalSame brand

🇳🇱Orfadin 2 mg, harde capsulesNetherlands · Capsule, hard · Swedish Orphan InternationalSame brand

🇷🇴ORFADIN 10mgRomania · 10mg · caps. · Swedish Orphan International ABSame brand

🇷🇴ORFADIN 2mgRomania · 2mg · caps. · Swedish Orphan International ABSame brand

🇷🇴ORFADIN 5mgRomania · 5mg · caps. · Swedish Orphan International ABSame brand

🇸🇦Orfadin 10 MG CapsuleSaudi Arabia · Apotek Produktion & Laboratorier ABSame brand

🇸🇦Orfadin 2 MG CapsuleSaudi Arabia · Apotek Produktion & Laboratorier ABSame brand

🇸🇦Orfadin 20 MG CapsuleSaudi Arabia · Apotek Produktion & Laboratorier ABSame brand

🇺🇸OrfadinUnited States · 4MG/ML · suspension · Swedish OrphanSame brand

🇺🇸OrfadinUnited States · 10MG, 20MG, 2MG … · capsule · Swedish OrphanSame brand

🇧🇷NitikabsBrazil · Pharmedic Pharmaceuticals, Importacao, Exportacao, Distribuicao, Comercio e Representacoes LtdaSame substance

🇪🇺NityrEuropean Union · Cycle Pharmaceuticals (Europe) LtdSame substance

🇪🇺Nitisinone MDK (previously Nitisinone MendeliKABS)European Union · MendeliKABS Europe LtdSame substance

🇭🇷NityrCroatiaSame substance

🇮🇹Nitisinone DipharmaItaly · Capsula rigida · Dipharma Arzneimittel GmbHSame substance

🇳🇿Nitisinone LogixX PharmaNew Zealand · Cap 2 mgSame substance

🇳🇿Nitisinone LogixX PharmaNew Zealand · Cap 10 mgSame substance

🇳🇿Nitisinone LogixX PharmaNew Zealand · Cap 5 mgSame substance

🇺🇸HarlikuUnited States · 2MG · tablet · CycleSame substance

Packs

Pack	Code	Status
ORFADIN 4 mg/ml SUSPENSION ORAL , 1 frasco de 90 ml	707150

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 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
Strength: 4,0 mg
Dosage form: suspensión oral
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 26 Jul 2015
Registration: 104303005
Marketing authorisation holder: Swedish Orphan Biovitrum International Ab
Procedure: EU centralised
Supply: Uso Hospitalario

AEMPSNitisinona Dipharma 20 MG Capsulas Duras EfgNitisinone · 20 mg · cápsula dura🇪🇸Spain

AEMPSNitisinona Dipharma 5 MG Capsulas Duras EfgNitisinone · 5 mg · cápsula dura🇪🇸Spain

AEMPSNitisinone MDK 10 MG Capsulas DurasNitisinone · 10 mg · cápsula dura🇪🇸Spain

AEMPSNitisinone MDK 2 MG Capsulas DurasNitisinone · 2 mg · cápsula dura🇪🇸Spain

AEMPSNitisinone MDK 5 MG Capsulas DurasNitisinone · 5 mg · cápsula dura🇪🇸Spain

AEMPSORFADIN 10 mg CAPSULAS DURASNitisinone · 10 mg · cápsula dura🇪🇸Spain

AEMPSORFADIN 2 mg CAPSULAS DURASNitisinone · 2 mg · cápsula dura🇪🇸Spain

AEMPSORFADIN 20 mg CAPSULAS DURASNitisinone · 20 mg · cápsula dura🇪🇸Spain

AEMPSORFADIN 5 mg CAPSULAS DURASNitisinone · 5 mg · cápsula dura🇪🇸Spain