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HSA Approval

Akeega Film-coated Tablets 50mg/500mg

Approval Number

SIN17109P

Drug Name

Akeega Film-coated Tablets 50mg/500mg

Product Name

Akeega Film-coated Tablets 50mg/500mg

Approval Date

October 14, 2024

Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Regulatory Information

Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

TABLET, FILM COATED

Route of Administration

ORAL

Medical Information

ATC Code

L01XK

Manufacturer Information

Pharmaceutical Manufacturer

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.

Manufacturers

Patheon France

Active Ingredients

Ingredient Name

Abiraterone acetate

Strength

500mg

Drug MonographAbiraterone

Ingredient Name

Niraparib tosylate monohydrate eqv niraparib

Strength

50mg

Drug MonographNiraparib

Documents

Package Inserts

Akeega Film-coated Tablets PI.pdf

Approved: October 14, 2024

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