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Opsynvi Film-coated Tablets 10mg/40mg - HSA Drug Approval Details

Approvals/HSA/Opsynvi Film-coated Tablets 10mg/40mg

Approved

THERAPEUTIC

Opsynvi Film-coated Tablets 10mg/40mg

Penn Pharmaceutical Services Limited🇸🇬 Health Sciences Authority

Approval Date: May 22, 2025
Approval ID: fbd007a93a087737
Company: Penn Pharmaceutical Services Limited
Type: Therapeutic

Approval Details

Approval Id: fbd007a93a087737
Drug Name: Opsynvi Film-coated Tablets 10mg/40mg
Product Name: Opsynvi Film-coated Tablets 10mg/40mg
Approval Number: SIN17242P
Approval Date: 2025-05-22
Registrant: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET, FILM COATED
Route Of Administration: ORAL
Atc Code: C02KX54
Pharma Manufacturer Name: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
Company Detail Path: /organization/6cc7da6f3b9c1cd6/johnson-and-johnson-international-singapore-pte-ltd

Active Ingredients

Macitentan

10mg

Tadalafil

40mg

Macitentan

10mg

Tadalafil

40mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 22, 2025

Approval ID

fbd007a93a087737

Type

Therapeutic

Back to HSA Approvals