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Medicines
Spain
Mirabegron

AEMPS 2024

Mirabegron

Mirabegron Normon 50 MG Comprimidos de Liberacion Prolongada Efg

50 mg comprimido de liberación prolongadaSpainAuthorisedAuthorised 9 Apr 2024

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.

Apo-MirabegronCanada · 25 MG · Tablet (Extended-Release) · Apotex INCSame form
Apo-MirabegronCanada · 50 MG · Tablet (Extended-Release) · Apotex INCSame form
Auro-MirabegronCanada · 50 MG · Tablet (Extended-Release) · Auro Pharma INCSame form
Iretig 50 mg tablete s produljenim oslobađanjemCroatia · Tableta s produljenim oslobađanjem · Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag, ČeškaSame form
Mezyran 25 mg tablete s produljenim oslobađanjemCroatia · Tableta s produljenim oslobađanjem · Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, HrvatskaSame form
Mezyran 50 mg tablete s produljenim oslobađanjemCroatia · Tableta s produljenim oslobađanjem · Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, HrvatskaSame form

More with the same substance on this register

BETMIGA 50mg comprimidos de liberacion prolongadaMirabegron · 50 mg · comprimido de liberación prolongadaSpain
Baxirto 50 MG Comprimidos de Liberacion Prolongada EfgMirabegron · 50 mg · comprimido de liberación prolongada

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.

🇮🇹BetmigaItaly · Compressa a rilascio prolungato · Astellas Pharma Europe B.V.Same form

🇮🇹BetmigaItaly · Compressa a rilascio prolungato · GMM Farma S.R.L.Same form

🇮🇹BetmigaItaly · Compressa a rilascio prolungato · Programmi Sanitari Integrati S.R.L.Same form

🇳🇱Betmiga 25 mg, tabletten met verlengde afgifteNetherlands · Tablet met verlengde afgifte · Astellas Pharma Europe B.V.Same form

🇳🇱Betmiga 50 mg, tabletten met verlengde afgifteNetherlands · Tablet met verlengde afgifte · Astellas Pharma Europe B.V.Same form

🇳🇱Mirabegron CF 25 mg, tabletten met verlengde afgifteNetherlands · Tablet met verlengde afgifte · Centrafarm B.V.Same form

🇸🇦BETMIGA 25 mg Prolonged Release Film Coted TabletSaudi Arabia · Saja-Saudi Arabian Japanese Pharmaceutical CoSame form

🇸🇦BETMIGA 50 mg Prolonged Release Film Coted TabletSaudi Arabia · Saja-Saudi Arabian Japanese Pharmaceutical CoSame form

🇸🇬Betmiga ® Prolonged-Release Tablets 25MGSingapore · 25 mg · tablet, film coated, extended release · Astellas Pharma Singapore Pte. LTD.Same form

🇸🇬Betmiga ® Prolonged-Release Tablets 50MGSingapore · 50 mg · tablet, film coated, extended release · Astellas Pharma Singapore Pte. LTD.Same form

🇺🇸MirabegronUnited States · 25MG, 50MG · tablet, extended release · LupinSame form

🇺🇸MyrbetriqUnited States · 25MG, 50MG · tablet, extended release · ApgdiSame form

🇺🇸MirabegronUnited States · 25MG · tablet, extended release · Sunshine Lake Pharma Co LTDSame form

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

🇧🇷MicpureBrazil · Apsen Farmaceutica S/ASame substance

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

🇪🇺BetmigaEuropean Union · Astellas Pharma Europe B.V.Same substance

🇷🇴BETMIGA 25mgRomania · 25mg · compr. elib. prel. · Astellas Pharma Europe B.V.Same substance

🇷🇴BETMIGA 50mgRomania · 50mg · compr. elib. prel. · Astellas Pharma Europe B.V.Same substance

Packs

Pack	Code	Status
MIRABEGRON NORMON 50 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG, 30 comprimidos	764650

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: Mirabegron
Strength: 50 mg
Dosage form: comprimido de liberación prolongada
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 9 Apr 2024
Registration: 89487
Marketing authorisation holder: Laboratorios Normon S.A.
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica

🇪🇸Spain

AEMPSIretig 50 MG Comprimidos de Liberacion Prolongada EfgMirabegron · 50 mg · comprimido de liberación prolongada🇪🇸Spain

AEMPSMirabegron Alter 50 MG Comprimidos de Liberacion Prolongada EfgMirabegron · 50 mg · comprimido de liberación prolongada🇪🇸Spain

AEMPSMirabegron Cinfamed 50 MG Comprimidos de Liberacion Prolongada EfgMirabegron · 50 mg · comprimido de liberación prolongada🇪🇸Spain

AEMPSMirabegron Stada 50 MG Comprimidos de Liberacion Prolongada EfgMirabegron · 50 mg · comprimido de liberación prolongada🇪🇸Spain

AEMPSMirabegron Teva 50 MG Comprimidos de Liberacion Prolongada EfgMirabegron · 50 mg · comprimido de liberación prolongada🇪🇸Spain

AEMPSQumigrona 50 MG Comprimidos de Liberación Prolongada EfgMirabegron · 50 mg · comprimido de liberación prolongada🇪🇸Spain