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HSA Product

BETMIGA ® PROLONGED-RELEASE TABLETS 50MG

Product approved by Health Sciences Authority (SG)

Basic Information

BETMIGA ® PROLONGED-RELEASE TABLETS 50MG

TABLET, FILM COATED, EXTENDED RELEASE

Regulatory Information

SIN14623P

September 15, 2014

Prescription Only

Therapeutic

ORAL

August 10, 2023

May 30, 2025

XG04BD12

Company Information

ASTELLAS PHARMA SINGAPORE PTE. LTD.

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Active Ingredients

Mirabegron

Strength: 50 mg

Detailed Information

Contraindications

**4.3 Contraindications** Mirabegron is contraindicated in patients with - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg.

Indication Information

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

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