In other countries
The same active substances on other registers, the same brand first.
- Apo-MirabegronCanada · 50 MG · Tablet (Extended-Release) · Apotex INCSame form
- Apo-MirabegronCanada · 25 MG · Tablet (Extended-Release) · Apotex INCSame form
- Auro-MirabegronCanada · 50 MG · Tablet (Extended-Release) · Auro Pharma INCSame form
- BETMIGA 50mg comprimidos de liberacion prolongadaSpain · 50 mg · comprimido de liberación prolongada · Astellas Pharma Europe B.V.Same form
- Baxirto 50 MG Comprimidos de Liberacion Prolongada EfgSpain · 50 mg · comprimido de liberación prolongada · Laboratorios Alter S.A.Same form
- Iretig 50 MG Comprimidos de Liberacion Prolongada EfgSpain · 50 mg · comprimido de liberación prolongada · Zentiva K.S.Same form
- 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 |
|---|---|---|
| 30 tableta u blisteru, u kutiji | HR-H-033230058-01 | nije stavljeno u promet |
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
HALMED — Agencija za lijekove i medicinske proizvode RH
HALMED, Baza lijekova, source export 08.10.2026., acquired 2026-10-08; factual structured adaptation; Otvorena dozvola RH, NN 67/2017.
Licence: Otvorena dozvola RH NN 67/2017 · Added 8 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
- Dosage form
- Tableta s produljenim oslobađanjem
- Register
- Croatia (HALMED)
- Status
- Not marketed
- Status in the register
- nije stavljeno u promet
- Authorised
- 15 Sept 2026
- Registration
- HR-H-033230058
- Marketing authorisation holder
- TEVA GmbH, Graf-Arco-Strasse 3, Ulm, Njemačka
- Manufacturer
- Adalvo Limited, San Gwann, Malta<br/>Pharmadox Healthcare Limited, Paola, Malta
- ATC code
- G04BD12
- Procedure
- National, MRP or DCP
- Supply
- na recept; u ljekarni