Mirabegron

Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.

39 MYRBETRIQ® Product Monograph Page 3 of 40 PrMYRBETRIQ® mirabegron PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Oral Extended-release tablets: 25 mg, 50 mg None For a complete listing see Dosage Forms, Composition and Packaging section.

INDICATIONS AND CLINICAL USE MYRBETRIQ (mirabegron) is indicated for the treatment of overactive bladder (OAB) with symptoms of urgency, urgency incontinence and urinary frequency. 9%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients younger than 65 years of age and those 65 years of age or older in these studies.

Pediatrics (< 18 years of age):

The safety and efficacy of MYRBETRIQ in pediatric patients have not been established. CONTRAINDICATIONS MYRBETRIQ is contraindicated in:  Patients with severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg.

1 INDICATIONS AND USAGE Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.

1 Adult Overactive Bladder (OAB) Mirabegron Extended-Release Tablets Monotherapy Mirabegron extended-release tablets are indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.

's MYRBETRIQ (mirabegron extended-release tablets). 's marketing exclusivity rights, this drug product is not labeled with that information.

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.