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OPSYNVI - Health Canada Drug Approval Details

Approvals/Health Canada/OPSYNVI

Authorized

STANDARD

OPSYNVI

Janssen Inc🇨🇦 Health Canada

Approval Date: Jul 4, 2025
Approval ID: fdb20cbcfca8d167
Company: Janssen Inc
Type: Standard

Approval Details

Approval Id: fdb20cbcfca8d167
Drug Approval Canada Name: OPSYNVI
Product Name: OPSYNVI
Status: Marketed
Status Date: 2021-11-25
Original Market Date: 2021-11-25
Din: 02521083
Drug Class: Human
Dosage Form: Tablet
Route Of Administration: Oral
Schedule: Prescription
Ahfs: 48:48.12
Atc Original: C02KX54 MACITENTAN AND TADALAFIL
Atc Name: c 02 kx 54
Aig Number: 0263194001
Company Name: Janssen Inc
Company Address: 19 Green Belt Drive, Toronto, Ontario, Canada, M3C 1L9
Company Detail Path: /organization/janssen-inc

Company Information

Pharmaceutical Company Name: Janssen Inc
Country Name: Canada
Province Name: Ontario
City Name: north york,ontario,country_ca
Address: 19 Green Belt Dr

Active Ingredients

MACITENTAN

10 MG

TADALAFIL

40 MG

Authorized

Quick Info

Agency

Health Canada

Country

🇨🇦

Approval Date

Jul 4, 2025

Approval ID

fdb20cbcfca8d167

Type

Standard

Back to Health Canada Approvals