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Medicines
Spain
Montelukast

AEMPS 2012

Montelukast

MONKASTA 4 mg COMPRIMIDOS MASTICABLES EFG

4,16 mg comprimido masticableSpainMarketedAuthorised 13 Feb 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.

Monkasta 10 mg filmom obložene tableteCroatia · filmom obložena tableta · Krka - farma d.o.o., Radnička cesta 48, Zagreb, HrvatskaSame brand
Monkasta 4 mg tablete za žvakanjeCroatia · tableta za žvakanje · Krka - farma d.o.o., Radnička cesta 48, Zagreb, HrvatskaSame brand
Monkasta 5 mg tablete za žvakanjeCroatia · tableta za žvakanje · Krka - farma d.o.o., Radnička cesta 48, Zagreb, HrvatskaSame brand
MonkastaItaly · Compressa masticabile · Krka D.D. Novo MestoSame brand
MONKASTA 10 mgRomania · 10mg · compr. film. · Krka D.D., Novo MestoSame brand
MONKASTA 4 mgRomania · 4mg · compr. mast. · Krka D.D., Novo MestoSame brand

More with the same substance on this register

MONKASTA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGMontelukast · 10,4 mg · comprimido recubierto con películaSpain
MONKASTA 5 mg COMPRIMIDOS MASTICABLES EFGMontelukast · 5,2 mg · comprimido masticable

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.

MONKASTA 5 mg

Romania · 5mg · compr. mast. · Krka D.D., Novo Mesto

Same brand

🇷🇸Monkasta®Serbia · 4mg · tableta za žvakanje · Krka-Farma D.O.O. BeogradSame brand

🇷🇸Monkasta®Serbia · 4mg · tableta za žvakanje · Krka-Farma D.O.O. BeogradSame brand

🇷🇸Monkasta®Serbia · 5mg · tableta za žvakanje · Krka-Farma D.O.O. BeogradSame brand

🇨🇦Ach-MontelukastCanada · 10 MG · Tablet · Accord Healthcare INCSame form

🇨🇦AG-MontelukastCanada · 10 MG · Tablet · Angita Pharma INC.Same form

🇨🇦Apo-MontelukastCanada · 4 MG · Tablet (Chewable) · Apotex INCSame form

🇮🇹AleastItaly · Compressa masticabile · Lanova Farmaceutici S.R.L.Same form

🇮🇹BrokastItaly · Compressa masticabile · A.G.I.P.S. Farmaceutici SRLSame form

🇳🇱Montelukast 10 mg Teva, filmomhulde tablettenNetherlands · Filmomhulde tablet · Teva Nederland B.V.Same form

🇳🇱Montelukast 4 mg Teva, kauwtablettenNetherlands · Kauwtablet · Teva Nederland B.V.Same form

🇳🇱Montelukast 5 mg Teva, kauwtablettenNetherlands · Kauwtablet · Teva Nederland B.V.Same form

🇳🇿Montelukast Paediatric (Relonchem)New Zealand · Tab 5 mgSame form

🇳🇿Montelukast (Sandoz)New Zealand · Tab 4 mgSame form

🇳🇿Montelukast ViatrisNew Zealand · Tab 5 mgSame form

🇸🇦ACTAMONE 4 mg chewable tabletSaudi Arabia · Deef Pharmaceutical IndustriesSame form

🇸🇦ACTAMONE 5 mg chewable tabletSaudi Arabia · Deef Pharmaceutical IndustriesSame form

🇸🇦Airfast 10MG Film Coated TabletSaudi Arabia · Tabuk Pharmaceutical Manufacturing Co.Same form

🇸🇬Klairmont Film-Coated Tablet 10MGSingapore · 10mg · tablet, film coated · Pharmakoe Pte. LTD.Same form

🇸🇬Lukakline Chewable Tablet 4mgSingapore · 4 mg · tablet, chewable · Zyfas Pharma Pte LTDSame form

🇸🇬Lukakline Chewable Tablet 5mgSingapore · 5 mg · tablet, chewable · Zyfas Pharma Pte LTDSame form

🇺🇸Montelukast SodiumUnited States · 10MG BASE · tablet · Torrent Pharms LTDSame form

🇺🇸Montelukast SodiumUnited States · 4MG BASE, 5MG BASE · tablet, chewable · Senores PharmsSame form

🇺🇸SingulairUnited States · 4MG BASE, 5MG BASE · tablet, chewable · OrganonSame form

🇧🇷ÁriaBrazil · Eurofarma Laboratorios S.A.Same substance

🇧🇷Fischio®Brazil · Biolab Sanus Farmacêutica LtdaSame substance

🇧🇷Fischio®Brazil · Biolab Sanus Farmacêutica LtdaSame substance

🇹🇼Monte-H 5 (Montelukast Chewable Tablets 5mg)Taiwan · 咀嚼錠 · 凱沛爾藥品有限公司Same substance

🇹🇼Sinlue Chewable Tablets 5mgTaiwan · 咀嚼錠 · 恆準醫藥有限公司Same substance

Packs

Pack	Code	Status
MONKASTA 4 mg COMPRIMIDOS MASTICABLES EFG , 28 comprimidos	675774

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: Montelukast
Strength: 4,16 mg
Dosage form: comprimido masticable
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 13 Feb 2012
Registration: 72930
Marketing authorisation holder: Krka D.D. Novo Mesto
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica

🇪🇸Spain

AEMPSMONTELUKAST ALMUS 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGMontelukast · 10,39 mg · comprimido recubierto con película🇪🇸Spain

AEMPSMONTELUKAST ALTER 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGMontelukast · 10,37 mg · comprimido recubierto con película🇪🇸Spain

AEMPSMONTELUKAST ALTER 4 mg COMPRIMIDOS MASTICABLES EFGMontelukast · 4,15 mg · comprimido masticable🇪🇸Spain

AEMPSMONTELUKAST ALTER 5 mg COMPRIMIDOS MASTICABLES EFGMontelukast · 5,19 mg · comprimido masticable🇪🇸Spain

AEMPSMONTELUKAST ASTHMAPHARMA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGMontelukast · 10,40 mg · comprimido recubierto con película🇪🇸Spain

AEMPSMONTELUKAST ASTHMAPHARMA 4 mg COMPRIMIDOS MASTICABLES EFGMontelukast · 4,00 mg · comprimido masticable🇪🇸Spain

AEMPSMONTELUKAST ASTHMAPHARMA 5 mg COMPRIMIDOS MASTICABLES EFGMontelukast · 5,00 mg · comprimido masticable🇪🇸Spain

AEMPSMontelukast Aurovitas 10 MG Comprimidos Recubiertos con Pelicula EfgMontelukast · 10,38 mg · comprimido recubierto con película🇪🇸Spain

AEMPSMontelukast Aurovitas 4 MG Comprimidos Masticables EfgMontelukast · 4,15 mg · comprimido masticable🇪🇸Spain

AEMPSMontelukast Aurovitas 5 MG Comprimidos Masticables EfgMontelukast · 5,19 mg · comprimido masticable🇪🇸Spain