Regulatory PathRegulatory requirements compared

Active substance

Verteporfin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
VISUDYNE 15MG POWDER FOR INFUSION15 mgPowder for solution for infusion · Intravenous use1 VialSAR 5422.85NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
VISUDYNE15MG/VIALinjectable · injectionBAUSCH LOMB IRELANDPrescription12 Apr 2000

EMA European Union — centrally authorised medicines

Visudyne CHEPLAPHARM Arzneimittel GmbH · Authorised · authorised 27 Jul 2000 · ATC S01LA01

Therapeutic indication (EMA)

Visudyne is indicated for the treatment of: adults with exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or; adults with subfoveal choroidal neovascularisation secondary to pathological myopia.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
VISUDYNE0224236715 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSCHEPLAPHARM ARZNEIMITTEL GMBH

Safety signals and safety-related labeling changes

All safety entries for verteporfin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.