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: Sodium oxybate
Strength: 500 mg
Dosage form: solución oral
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 20 Dec 2005
Registration: 05312001
Marketing authorisation holder: Ucb Pharma
Procedure: EU centralised
Supply: Uso Hospitalario. Psicótropos

Oxibato de Sodio Zentiva 500 MG/ML Solucion Oral EfgSodium oxybate · 500 mg/ml · solución oralSpain

Oxibato Sodico Sala 500 MG/ML Solucion Oral EfgSodium oxybate · 500 mg · solución oralSpain

Oxibato de Sodio Kalceks 500 MG/ML Solucion Oral EfgSodium oxybate · 500 mg · solución oralSpainSuspended