mirabegron
Betmiga · ATC code G04BD12
Brand names: Betmiga, Mirabegron +pharma, Mirabegron G.L., Mirabegron Genericon, Mirabegron Ratiopharm, Mirabegron Stada, Mirabegron Zentiva, Mirabegron Al, Mirabegron Aristo, Mirabegron Glenmark, Mirabegron Heumann, Begamir, Urotrexin
- Key facts
- Active substance
- mirabegron
- ATC code
- G04BD12
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Betmiga 25 mg prolonged-release tablets / Betmiga 50 mg prolonged-release tablets · Betmiga 8 mg/ml granules for prolonged-release oral suspension
- Marketing authorisation holder
- Astellas Pharma Europe B.V.
- Information as of
- 2026-10-27
Key facts
Mirabegron is a beta-3 adrenoceptor agonist used in adults with overactive bladder and in children and adolescents with neurogenic detrusor overactivity.
What it is used for
- Adults: symptomatic treatment of urgency, increased frequency and/or urgency incontinence in overactive bladder
- Children and adolescents aged 3 to <18 years: neurogenic detrusor overactivity (tablets or granules for suspension)
Dosing
- Overactive bladder, adults (including elderly): 50 mg once daily.
- Severe renal impairment (eGFR 15 to 29): 25 mg once daily; not recommended with strong CYP3A inhibitors.
- Mild to moderate renal or mild hepatic impairment with strong CYP3A inhibitors: no more than 25 mg.
- Children 35 kg or more (tablets): start 25 mg once daily with food, may increase to a maximum of 50 mg after 4 to 8 weeks.
- Children below 35 kg: granules for suspension, dosed by body weight (see full text).
- Not recommended in end stage renal disease, haemodialysis or severe hepatic impairment.
Contraindications
- Hypersensitivity to the active substance or any excipient
- Severe uncontrolled hypertension (systolic ≥180 mm Hg and/or diastolic ≥110 mm Hg)
Important warnings
- Can increase blood pressure; measure at baseline and periodically (increases may be larger in children)
- Caution in congenital or acquired QT prolongation
- Not recommended in moderate hepatic or severe renal impairment with strong CYP3A inhibitors
Side effects
- Most common in adults: urinary tract infections (2.9%) and tachycardia (1.2%)
- Serious: atrial fibrillation (0.2%)
- Most adverse reactions mild to moderate
Interactions
- Moderate CYP2D6 inhibitor: caution with narrow-therapeutic-index CYP2D6 substrates (e.g. thioridazine, flecainide, propafenone, tricyclic antidepressants)
- Digoxin: start with the lowest digoxin dose and monitor levels
- Strong CYP3A inhibitors: dose limits in renal or hepatic impairment
Pregnancy and breastfeeding
- Not recommended during pregnancy or in women of childbearing potential not using contraception.
- Should not be used during breast-feeding.
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- BetmigaAstellas Pharma Europe B.V. · EMEA/H/C/002388
Source: European Medicines Agency (EMA), product information
Austria
- Mirabegron +pharma+pharma Arzneimittel Gmbh · 1 register entry
- Mirabegron G.L.G.L. Pharma Gmbh · 1 register entry
- Mirabegron GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
- Mirabegron RatiopharmRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
- Mirabegron StadaStada Arzneimittel Gmbh · 1 register entry
- Mirabegron ZentivaZentiva, K.S. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Mirabegron AlAliud Pharma Gmbh · 1 register entry
- Mirabegron AristoAristo Pharma Gmbh (Art 57) · 1 register entry
- Mirabegron GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
- Mirabegron HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
- Mirabegron RatiopharmRatiopharm Gmbh · 1 register entry
- Mirabegron StadaStadapharm Gmbh · 1 register entry
- Mirabegron ZentivaZentiva Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- BegamirDEVA HOLDİNG A.Ş. · 14 register entries
- BetmigaASTELLAS PHARMA İLAÇ TİC. VE SAN. A.Ş. · 14 register entries
- UrotrexinSANTA FARMA İLAÇ SAN. A.Ş. · 14 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Mirabegron Eg, Mirabegron Teva, Mirabegron Zentiva
- Bulgaria
- Иретиг, Мирабегрон G.L., Мирабегрон Тева, Мирагрон
- Croatia
- Iretig, Mezyran, Minkonti, Mirabegron Genericon, Mirabegron Pharmas, Zenivox Altamedics, Zerjaq
- Cyprus
- Macitentan, Mirabegron
- Czechia
- Begirax, Iretig, Mirabegron Accord, Mirabegron G.L. Pharma, Mirabegron Stada, Mirabegron Teva, Zerjaq
- Denmark
- Mirabegron Glenmark, Mirabegron Stada, Mirabegron Teva, Mirabegron Zentiva
- Estonia
- Mirabegron Zentiva
- Finland
- Mirabegron Avansor, Mirabegron Glenmark, Mirabegron Ratiopharm, Mirabegron Stada, Mirabegron Zentiva
- France
- Mirabegron Zentiva
- Greece
- Iretig, Mirabegron Aristo Aristo, Mirabegron Stada, Mirabegron/Pharmazac, Viamira P.R.Tab
- Hungary
- Mirabegron Stada
- Iceland
- Betmiga, Iretig, Macitentan, Minkonti, Mirabegron
- Ireland
- Mirabegron Ascend, Mirabegron Clonmel, Mirabegron Teva
- Italy
- Iretig, Mirabegron Doc
- Latvia
- Mirabegron Zentiva
- Liechtenstein
- Betmiga
- Lithuania
- Mirabegron Zentiva
- Luxembourg
- Mirabegron Eg
- Malta
- Mirabegron
- Netherlands
- Mirabegron Cf, Mirabegron Glenmark, Mirabegron Teva, Mirabegron Zentiva
- Norway
- Betmiga, Mirabegron Glenmark, Mirabegron Stada, Mirabegron Teva, Mirabegron Zentiva
- Poland
- Begirax, Iretig, Mirabegron +pharma, Mirabegron Accord, Mirabegron G.L. Pharma, Mirabegron Teva
- Portugal
- Baxirto, Mirabegrom Alter, Mirabegrom Stada
- Romania
- Iretig, Mirabegron G.L. Pharma
- Slovakia
- Mirabegron Glenmark, Mirabegron Stada, Mirabegron Teva, Zerjaq
- Slovenia
- Gozi, Zerjaq
- Spain
- Baxirto, Iretig, Mirabegrón Alter, Mirabegrón Cinfamed, Mirabegrón Normon, Mirabegrón Stada, Mirabegrón Teva
- Sweden
- Mirabegron Avansor, Mirabegron Glenmark, Mirabegron Stada, Mirabegron Teva, Mirabegron Zentiva
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- European Medicines Agency. Betmiga – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/betmiga-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.