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Medicines
Spain
Hydromorphone

AEMPS 2025

Hydromorphone

Edunix 2,6 MG/ML Solucion Oral

2,6 mg/ml solución oralSpainMarketedAuthorised 14 Apr 2025

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.

Hydromorphone HP 10Canada · 10 MG / ML · Solution · Sandoz Canada IncorporatedSame strength and form
Hydromorphone HP 20Canada · 20 MG / ML · Solution · Sandoz Canada IncorporatedSame strength and form
Hydromorphone HP 50Canada · 50 MG / ML · Solution · Sandoz Canada IncorporatedSame strength and form
DilaudidBrazil · Abbott Laboratórios do Brasil LtdaSame substance
DilaudidBrazil · Knoll Prods Quims Farmaceuticos Ltda.Same substance
JurnistaBrazil · Janssen-Cilag Farmacêutica LtdaSame substance
MedepidolItaly · Compressa a rilascio prolungato · G.L. Pharma GMBHSame substance

More with the same substance on this register

Edunix 1,3 MG Capsulas Duras EfgHydromorphone · 1,3 mg · cápsula duraSpain
Edunix 16 MG Comprimidos de Liberacion ProlongadaHydromorphone · 16,00 mg · comprimido de liberación prolongadaSpain

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.

🇮🇹

TiblelanItaly · Compressa rivestita con film · G.L. Pharma GMBH

Same substance

🇳🇱Hydagelan 10 mg/ml oplossing voor injectie/infusieNetherlands · Oplossing voor injectie of infusie · G.L. Pharma GmbHSame substance

🇳🇱Hydagelan 2 mg/ ml oplossing voor injectie/infusieNetherlands · Oplossing voor injectie of infusie · G.L. Pharma GmbHSame substance

🇳🇱Hydagelan 20 mg/ml oplossing voor injectie/infusieNetherlands · Oplossing voor injectie of infusie · G.L. Pharma GmbHSame substance

🇷🇸Hidromorfon KalceksSerbia · 2mg/ml · rastvor za injekciju/infuziju · Rhei Life DOOSame substance

🇷🇸Hidromorfon KalceksSerbia · 20mg/ml · rastvor za injekciju/infuziju · Rhei Life DOOSame substance

🇷🇸Hidromorfon KalceksSerbia · 10mg/ml · rastvor za injekciju/infuziju · Rhei Life DOOSame substance

🇸🇦JURNISTA 16 mg prolonged-release tabletSaudi Arabia · Alza CorporationSame substance

🇸🇦JURNISTA 32 mg prolonged-release tabletSaudi Arabia · Alza CorporationSame substance

🇸🇦JURNISTA 64 mg prolonged-release tabletSaudi Arabia · Alza CorporationSame substance

🇺🇸Hydromorphone HydrochlorideUnited States · 0.25MG/0.5ML, 0.2MG/ML, 0.5MG/0.5ML … · injectable · BarrSame substance

🇺🇸DilaudidUnited States · 0.2MG/ML, 0.5MG/0.5ML, 1MG/ML … · injectable · Fresenius Kabi USASame substance

🇺🇸Dilaudid-HPUnited States · 10MG/ML, 250MG/VIAL · injectable · Fresenius Kabi USASame substance

Packs

Pack	Code	Status
EDUNIX 2,6 MG/ML SOLUCION ORAL, 1 frasco de 20 ml	767341
EDUNIX 2,6 MG/ML SOLUCION ORAL, 1 frasco de 50 ml	767492

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: Hydromorphone
Strength: 2,6 mg/ml
Dosage form: solución oral
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 14 Apr 2025
Registration: 90236
Marketing authorisation holder: Aristo Pharma Gmbh
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica. Estupefacientes

🇪🇸

AEMPSEdunix 2,6 MG Capsulas Duras EfgHydromorphone · 2,6 mg · cápsula dura🇪🇸Spain

AEMPSEdunix 32 MG Comprimidos de Liberacion ProlongadaHydromorphone · 32,00 mg · comprimido de liberación prolongada🇪🇸Spain

AEMPSEdunix 4 MG Comprimidos de Liberacion ProlongadaHydromorphone · 4,00 mg · comprimido de liberación prolongada🇪🇸Spain

AEMPSEdunix 8 MG Comprimidos de Liberacion ProlongadaHydromorphone · 8,00 mg · comprimido de liberación prolongada🇪🇸Spain

AEMPSJURNISTA 16 mg COMPRIMIDOS DE LIBERACION PROLONGADAHydromorphone · 16,35 mg · comprimido de liberación prolongada🇪🇸SpainWithdrawn

AEMPSJURNISTA 32 mg COMPRIMIDOS DE LIBERACION PROLONGADAHydromorphone · 32 mg · comprimido de liberación prolongada🇪🇸SpainWithdrawn

AEMPSJURNISTA 4 mg COMPRIMIDOS DE LIBERACION PROLONGADAHydromorphone · 4,36 mg · comprimido de liberación prolongada🇪🇸SpainWithdrawn

AEMPSJURNISTA 8 mg COMPRIMIDOS DE LIBERACION PROLONGADAHydromorphone · 8,72 mg · comprimido de liberación prolongada🇪🇸SpainWithdrawn