MedPath
HSA Approval

Opsynvi Film-coated Tablets 10mg/20mg

SIN17241P

Opsynvi Film-coated Tablets 10mg/20mg

Opsynvi Film-coated Tablets 10mg/20mg

May 22, 2025

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantJOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

TABLET, FILM COATED

ORAL

Medical Information

C02KX54

Manufacturer Information

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.

Penn Pharmaceutical Services Limited

Active Ingredients

Macitentan

10mg

Macitentan

Tadalafil

20mg

Tadalafil

Documents

Package Inserts

Opsynvi PI.pdf

Approved: May 22, 2025

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Opsynvi Film-coated Tablets 10mg/20mg - HSA Approval | MedPath