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Medicines
Spain
Mesalazine

AEMPS 2023

Mesalazine

Blenix 1.000 MG Comprimidos Gastrorresistentes

500 mg comprimido gastrorresistenteSpainAuthorisedAuthorised 27 Oct 2023

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.

MezavantCanada · 1.2 G · Tablet (Delayed- And Extended-Release) · Takeda Canada INCSame form
MezeraCanada · 500 MG · Tablet (Delayed-Release) · Avir Pharma INC.Same form
MezeraCanada · 1 G · Tablet (Delayed-Release) · Avir Pharma INC.Same form
Pentasa 1 g tablete s produljenim oslobađanjemCroatia · tableta s produljenim oslobađanjem · Ferring GmbH, Wittland 11, Kiel, NjemačkaSame form
Pentasa 500 mg tablete s produljenim oslobađanjemCroatia · tableta s produljenim oslobađanjem · Ferring GmbH, Wittland 11, Kiel, NjemačkaSame form
Salofalk 500 mg želučanootporne tableteCroatia · želučanootporna tableta · Dr. Falk Pharma GmbH, Leinenweberstraße 5, Freiburg, NjemačkaSame form

More with the same substance on this register

Asacol 1.600 MG Comprimidos GastrorresistentesMesalazine · 1.600 mg · comprimido gastrorresistenteSpain
Asacol 1 G SupositoriosMesalazine · 1 g · supositorioSpain

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.

🇮🇹

ArgonalItaly · Compressa gastroresistente · Dicofarm S.P.A.

Same form

🇮🇹AsacolItaly · Compressa gastroresistente · Giuliani SPASame form

🇮🇹AsalexItaly · Compressa a rilascio modificato · Chiesi Farmaceutici S.P.A.Same form

🇳🇱Asacol 400 tablet, maagsapresistente tabletten 400 mgNetherlands · Maagsapresistente tablet · pharmaand GmbHSame form

🇳🇱Asacol 800 tablet, maagsapresistente tabletten 800 mgNetherlands · Maagsapresistente tablet · pharmaand GmbHSame form

🇳🇱Azzavix 1000 mg maagsapresistente tablettenNetherlands · Maagsapresistente tablet · Medcor Pharmaceuticals B.V.Same form

🇳🇿AsacolNew Zealand · Tab 1,600 mgSame form

🇳🇿AsacolNew Zealand · Tab 400 mgSame form

🇳🇿AsacolNew Zealand · Tab EC 400 mgSame form

🇷🇸5-Asa®Serbia · 250mg · gastrorezistentna tableta · Slaviamed DOO BeogradSame form

🇷🇸Asacol®Serbia · 400mg · gastrorezistentna tableta · Pontus Pharma D.O.O. BeogradSame form

🇷🇸Asacol®Serbia · 1600mg · tableta sa modifikovanim oslobađanjem · Pontus Pharma D.O.O. BeogradSame form

🇸🇦Asacol 400MG F.C TabSaudi Arabia · Wulfing PharmaSame form

🇸🇦Asacol 800MG Gastro-Resistant TabletsSaudi Arabia · Wulfing PharmaSame form

🇸🇦Mezacol 400 MG E.C TabletSaudi Arabia · The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Same form

🇸🇬Asacol Tablet 800mgSingapore · 800mg · tablet, enteric coated · Wellchem Pharmaceuticals Pte LTDSame form

🇸🇬Mezavant XL Gastro-Resistant Prolonged Release Tablet 1200MGSingapore · 1200.0mg · tablet, delayed release · Takeda Pharmaceuticals (Asia Pacific) Pte. LTD.Same form

🇸🇬Pentasa Prolonged Release Tablets 1GSingapore · 1000 mg · tablet · Ferring Pharmaceuticals Private LimitedSame form

🇺🇸LialdaUnited States · 1.2GM · tablet, delayed release · Takeda Pharms USASame form

🇺🇸MesalamineUnited States · 1.2GM, 800MG · tablet, delayed release · Zydus PharmsSame form

🇺🇸AsacolUnited States · 400MG · tablet, delayed release · ApilSame form

🇧🇷Chron-Asa 5Brazil · Ems Sigma Pharma LtdaSame substance

🇧🇷MesacolBrazil · Takeda Pharma Ltda.Same substance

🇧🇷MesacolBrazil · Takeda Pharma Ltda.Same substance

🇷🇴MESALAZINA SOFARFARM 400 mgRomania · 400mg · compr. gastrorezistente · Sofarfarm S.R.L.Same substance

🇷🇴MESALAZINA SOFARFARM 800 mgRomania · 800mg · compr. gastrorezistente · Sofarfarm S.R.L.Same substance

🇷🇴PENTASA 1 gRomania · 1g · compr. elib. prel. · Ferring GMBHSame substance

Packs

Pack	Code	Status
BLENIX 1.000 MG COMPRIMIDOS GASTRORRESISTENTES, 100 comprimidos	763637
BLENIX 1.000 MG COMPRIMIDOS GASTRORRESISTENTES, 60 comprimidos	763638

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: Mesalazine
Strength: 500 mg
Dosage form: comprimido gastrorresistente
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 27 Oct 2023
Registration: 89105
Marketing authorisation holder: Faes Farma S.A.
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración

AEMPSASACOL 400 mg COMPRIMIDOS GASTRORRESISTENTESMesalazine · 400 mg · comprimido gastrorresistente🇪🇸Spain

AEMPSAsacol 800 MG Comprimidos GastrorresistentesMesalazine · 800 mg · comprimido gastrorresistente🇪🇸Spain

AEMPSClaversal 1 G Comprimidos GastrorresistentesMesalazine · 1000 mg · comprimido gastrorresistente🇪🇸Spain

AEMPSCLAVERSAL 500 mg COMPRIMIDOS GASTRORRESISTENTESMesalazine · 500 mg · comprimido gastrorresistente🇪🇸Spain

AEMPSCLAVERSAL 500 mg SUPOSITORIOSMesalazine · 500 mg · supositorio🇪🇸Spain

AEMPSClaversal Espuma RectalMesalazine · 1,066 g · espuma rectal🇪🇸Spain

AEMPSMEZAVANT 1.200 mg COMPRIMIDOS DE LIBERACION PROLONGADA GASTRORRESISTENTESMesalazine · 1200 mg · comprimido de liberación prolongada🇪🇸Spain

AEMPSPentasa 1 G Comprimidos de Liberacion ProlongadaMesalazine · 1 g · comprimido de liberación prolongada🇪🇸Spain

AEMPSPENTASA 1 g SUPOSITORIOSMesalazine · 1 g · supositorio🇪🇸Spain

AEMPSPentasa 1 G Suspension RectalMesalazine · 1 g · suspensión rectal🇪🇸Spain