Is Mirabegron registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Mirabegron, including BETMIGA 25 mg Prolonged Release Film Coted Tablet (25 mg, Prolonged-release film-coated tablet, SAR 142.95); BETMIGA 50 mg Prolonged Release Film Coted Tablet (50 mg, Prolonged-release film-coated tablet, SAR 183.90).

Is Mirabegron approved by the US FDA?

Drugs@FDA lists 13 application product lines for Mirabegron, including MYRBETRIQ (Prescription); MYRBETRIQ GRANULES (Prescription); MIRABEGRON (Prescription); MIRABEGRON (Prescription); MIRABEGRON (Prescription).

Is Mirabegron authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mirabegron: Betmiga.

Are there safety signals or safety updates for Mirabegron?

EMA PRAC: 1 entry; US FDA: 1 entry; MHRA: 1 entry (latest 2021-03-25).

Active substance

Mirabegron

SFDA 2
US FDA 13
EMA 1
Health Canada 5
US price lines 5
NHS prices 2
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BETMIGA 25 mg Prolonged Release Film Coted Tablet	25 mg	Prolonged-release film-coated tablet · Oral use	30 Blister	SAR 142.95	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
BETMIGA 50 mg Prolonged Release Film Coted Tablet	50 mg	Prolonged-release film-coated tablet · Oral use	30 Blister	SAR 183.90	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid

Indications — CHI Daman Drug Formulary

BENIGN PROSTATIC HYPERTROPHY; NOCTURNAL ENURESIS; URINARY INCONTINENCE AND OVERACTIVE BLADDER

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
MYRBETRIQ	25MG; 50MG	tablet, extended release · oral	APGDI	Prescription	28 Jun 2012
MYRBETRIQ GRANULES	8MG/ML	for suspension, extended release · oral	APGDI	Prescription	25 Mar 2021
MIRABEGRON	25MG; 50MG	tablet, extended release · oral	LUPIN	Prescription	28 Sep 2022
MIRABEGRON	25MG; 50MG	tablet, extended release · oral	ZYDUS PHARMS	Prescription	29 Sep 2022
MIRABEGRON	25MG; 50MG	tablet, extended release · oral	ALKEM LABS LTD	Prescription	12 Feb 2024
MIRABEGRON	25MG; 50MG	tablet, extended release · oral	QILU	Prescription	30 Jun 2025
MIRABEGRON	25MG; 50MG	tablet, extended release · oral	MSN	Prescription	4 Nov 2025
MIRABEGRON	8MG/ML	for suspension, extended release · oral	ALKEM LABS LTD	Prescription	20 Jan 2026
MIRABEGRON	25MG; 50MG	tablet, extended release · oral	DEVA HOLDING AS	Prescription	1 May 2026
MIRABEGRON	25MG; 50MG	tablet, extended release · oral	CREEKWOOD PHARMS	Prescription
MIRABEGRON	25MG	tablet, extended release · oral	SAWAI USA	Discontinued	27 Dec 2019
MIRABEGRON	25MG; 50MG	tablet, extended release · oral	APOTEX	Discontinued	2 Jan 2025
MIRABEGRON	50MG	tablet, extended release · oral	SAWAI USA	Discontinued	6 May 2025

EMA European Union — centrally authorised medicines

Betmiga Astellas Pharma Europe B.V. · Authorised · authorised 20 Dec 2012 · ATC G04BD12

Therapeutic indication (EMA)

Overactive bladder in adults Betmiga prolonged-release tablets are indicated for symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Neurogenic detrusor overactivity in the paediatric population Betmiga prolonged release tablets are indicated for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-MIRABEGRON	02564963	25 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
APO-MIRABEGRON	02564971	50 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
AURO-MIRABEGRON	02564955	50 MG	TABLET (EXTENDED-RELEASE) · ORAL	AURO PHARMA INC
MYRBETRIQ	02402874	25 MG	TABLET (EXTENDED-RELEASE) · ORAL	ASTELLAS PHARMA CANADA INC
MYRBETRIQ	02402882	50 MG	TABLET (EXTENDED-RELEASE) · ORAL	ASTELLAS PHARMA CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	MIRABEGRON ER 25 MG TABLET	$9.17671	per EA	23 Sep 2026
US NADAC	MIRABEGRON ER 50 MG TABLET	$9.38658	per EA	23 Sep 2026
US NADAC	MYRBETRIQ ER 25 MG TABLET	$14.67843	per EA	23 Sep 2026
US NADAC	MYRBETRIQ ER 50 MG TABLET	$14.69886	per EA	23 Sep 2026
US NADAC	MYRBETRIQ ER 8 MG/ML SUSP	$2.20702	per ML	23 Sep 2026
NHS Drug Tariff	Mirabegron 25mg modified-release tablets	£29.00	30 tablet	1 Oct 2026
NHS Drug Tariff	Mirabegron 50mg modified-release tablets	£29.00	30 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 25 Mar 2021 MYRBETRIQ — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 14 Oct 2015 Mirabegron (Betmiga▼): risk of severe hypertension and associated cerebrovascular and cardiac events
Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
EMA PRAC 16 May 2013 PRAC signal: Urinary retention
Action for MAH: update of the product information: No

All safety entries for mirabegron →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.