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Medicines
Spain
Ondansetron

AEMPS 2012

Ondansetron

SETOFILM 8 mg PELICULAS BUCODISPERSABLES EFG

8 mg pelicula bucodispersableSpainMarketedAuthorised 9 May 2012

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.

SetofilmItaly · Compressa orodispersibile · Norgine Italia S.R.L.Same brand
AnsentronBrazil · Aché Laboratórios Farmacêuticos S.ASame form
Cloridrato de OndansentronaBrazil · União Química Farmacêutica Nacional S/ASame form
cloridrato de ondansetronaBrazil · União Química Farmacêutica Nacional S/ASame form
Jamp Ondansetron OdfCanada · 4 MG · Film (Soluble) · Jamp Pharma CorporationSame form
Jamp Ondansetron OdfCanada · 8 MG · Film (Soluble) · Jamp Pharma CorporationSame form
Ondissolve OdfCanada · 8 MG · Film (Soluble) · Takeda Canada INCSame form

More with the same substance on this register

ONDANSETRON ACCORD 2 mg/ml SOLUCION INYECTABLE EFGOndansetron · 2 mg · solución inyectableSpain
Ondansetron Aristo 4 MG Comprimidos Bucodispersables EfgOndansetron · 4 mg · comprimido bucodispersable

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.

🇳🇱Ondansetron 4 mg/5 ml Focus Care, StroopNetherlands · Stroop · Focus Care Pharmaceuticals B.V.Same form

🇳🇱Ondansetron Eureco-Pharma stroop 4 mg/5 mlNetherlands · Stroop · Eureco-Pharma B.V.Same form

🇳🇱Ondansetron Medcor stroop 4 mg/5 mlNetherlands · Stroop · Medcor Pharmaceuticals B.V.Same form

🇷🇴OSETRON 4 mgRomania · 4mg · compr. film. · DR. Reddy'S Laboratories Romania S.R.L.Same form

🇷🇴OSETRON 8 mgRomania · 8mg · compr. film. · DR. Reddy'S Laboratories Romania S.R.L.Same form

🇸🇦Emedan 4 mg / 2 mlSaudi Arabia · Pharmathen InternationalSame form

🇸🇦Emedan 8 mg / 4 mlSaudi Arabia · Pharmathen InternationalSame form

🇸🇦IvonsanSaudi Arabia · Eva PharmaSame form

🇺🇸ZuplenzUnited States · 4MG, 8MG · film · AquestiveSame form

🇭🇷Ondanzetron Kabi 2 mg/ml otopina za injekciju/infuzijuCroatia · Otopina za injekciju / infuziju · Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, HrvatskaSame substance

🇭🇷Zofran 8 mg filmom obložene tableteCroatia · filmom obložena tableta · Sandoz d.o.o., Maksimirska 120, Zagreb, HrvatskaSame substance

🇭🇷Ondanzetron Kabi 0,08 mg/ml otopina za infuziju*Croatia · Otopina za infuziju · Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, HrvatskaSame substance

🇮🇹EmistopItaly · Soluzione iniettabile · Baxter Holding BVSame substance

🇮🇹Ondansetron AccordItaly · Soluzione iniettabile/infusione in siringa pre-riempita · Accord Healthcare, S.L.U.Same substance

🇳🇿Ondansetron-AFTNew Zealand · Inj 2 mg per ml, 2 ml ampouleSame substance

🇳🇿Ondansetron-AFTNew Zealand · Inj 2 mg per ml, 4 ml ampouleSame substance

🇳🇿PerisetNew Zealand · Tab 8 mgSame substance

🇷🇴ONDANSETRON AUROBINDO 2 mg/mlRomania · 2mg/ml · sol inj./perf. · Aurobindo Pharma Romania S.R.L.Same substance

🇷🇸Onda®Serbia · 8mg/4mL · rastvor za injekciju · Beocompass DOO BeogradSame substance

🇷🇸Onda®Serbia · 8mg · film tableta · Beocompass DOO BeogradSame substance

🇷🇸Onda®Serbia · 4mg/2mL · rastvor za injekciju · Beocompass DOO BeogradSame substance

🇸🇬NATZO 4 TABLETS 4mgSingapore · 4 mg · tablet · Natco Pharma Asia Pte. LTD.Same substance

🇸🇬NATZO 8 TABLETS 8 mgSingapore · 8.0 mg · tablet · Natco Pharma Asia Pte. LTD.Same substance

🇸🇬ODNATRON Film Coated tablet 8 mgSingapore · 8mg · tablet, film coated · Pharmakoe Pte. LTD.Same substance

🇺🇸OndansetronUnited States · 16MG, 24MG, 4MG … · tablet, orally disintegrating · Nesher PharmsSame substance

🇺🇸Ondansetron HydrochlorideUnited States · 16MG, 16MG BASE, 24MG BASE … · tablet · Chartwell RXSame substance

Packs

Pack	Code	Status
SETOFILM 8 mg PELICULAS BUCODISPERSABLES EFG , 10 sobres	676232

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: Ondansetron
Strength: 8 mg
Dosage form: pelicula bucodispersable
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 9 May 2012
Registration: 73006
Marketing authorisation holder: Norgine De Espana S.L.U.
Procedure: National, MRP or DCP
Supply: Diagnóstico Hospitalario

🇪🇸Spain

AEMPSOndansetron Aristo 8 MG Comprimidos Bucodispersables EfgOndansetron · 8 mg · comprimido bucodispersable🇪🇸Spain

AEMPSOndansetron Aristo 8 MG Comprimidos Recubiertos con Película EfgOndansetron · 9,972 mg · comprimido recubierto con película🇪🇸Spain

AEMPSOndansetron B. Braun 0,08 MG/ML Solucion Para PerfusionOndansetron · 0,10 mg · solución para perfusión🇪🇸Spain

AEMPSOndansetron B. Braun 0,16 MG/ML Solucion Para PerfusionOndansetron · 0,200 mg · solución para perfusión🇪🇸Spain

AEMPSOndansetron Bluefish 4 MG Comprimidos Bucodispersables EfgOndansetron · 4 mg · comprimido bucodispersable🇪🇸Spain

AEMPSOndansetron Bluefish 8 MG Comprimidos Bucodispersables EfgOndansetron · 8 mg · comprimido bucodispersable🇪🇸Spain

AEMPSONDANSETRON FRESENIUS KABI 2 mg/ml SOLUCION INYECTABLE EFGOndansetron · 5 mg · solución inyectable🇪🇸Spain

AEMPSOndansetron Kabi 0,16 MG/ML Solucion Para PerfusionOndansetron · 0,2 mg · solución para perfusión🇪🇸Spain

AEMPSONDANSETRON NORMON 4 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGOndansetron · 5 mg · comprimido recubierto con película🇪🇸Spain

AEMPSONDANSETRON NORMON 4mg/2 ml SOLUCION INYECTABLE EFGOndansetron · 5 mg · solución inyectable🇪🇸Spain