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HSA Product

EVENITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105 MG/1.17 ML

Product approved by Health Sciences Authority (SG)

Basic Information

EVENITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105 MG/1.17 ML

INJECTION, SOLUTION

Regulatory Information

SIN16208P

May 27, 2021

Prescription Only

Therapeutic

SUBCUTANEOUS

August 10, 2023

June 4, 2025

XM05BX06

Company Information

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Active Ingredients

Romosozumab

Strength: 105 mg/1.17 mL

Detailed Information

Contraindications

**4.3 Contraindications** Hypocalcaemia EVENITY is contraindicated in patients with uncorrected hypocalcaemia \[see Special Warnings and Precautions for Use (4.4), Adverse Reactions (4.8), and Special Populations (4.6) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. Hypersensitivity EVENITY is contraindicated in patients with known clinically significant hypersensitivity to romosozumab or to any component of the product formulation \[see Special Warnings and Precautions for Use (4.4) and List of Excipients (6.1) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. Myocardial Infarction and Stroke EVENITY is contraindicated in patients with a history of myocardial infarction or stroke \[see Special Warnings and Precautions for Use (4.4) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].

Indication Information

**4.1 Therapeutic Indications** Postmenopausal Osteoporosis EVENITY is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

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