Regulatory PathRegulatory requirements compared

Active substance

Indocyanine green

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Verdye5 mg/mlpowder for solution for injection · Intravitreal use5 VialSAR 458.15Generic · PrescriptionDiagnostic Green GmbHValid

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

ProductStrengthForm · routeApplicantStatusFirst approved
IC-GREEN25MG/VIAL; 10MG/VIALinjectable · injectionRENEW PHARMSPrescription9 Feb 1959
INDOCYANINE GREEN25MG/VIALinjectable · injectionRENEW PHARMSPrescription21 Nov 2007
SPY AGENT GREEN KIT25MG/VIALpowder · intravenous, interstitialNOVADAQ TECHPrescription21 Nov 2018
ZYOGREEN25MG/10ML (2.5MG/ML)solution · intravenous, interstitialPROVEPHARM SASPrescription10 Jul 2026
INDOCYANINE GREEN25MG/VIALinjectable · injectionZYDUS LIFESCIENCESPrescription3 Aug 2026
IC-GREEN50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionRENEW PHARMSDiscontinued9 Feb 1959

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
INDOCYANINE GREEN FOR INJECTION, USP0248579625 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSDIAGNOSTIC GREEN LIMITED
SPY AGENT GREEN0248365325 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTERSTITIAL; INTRADERMALNOVADAQ TECHNOLOGIES ULC
SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT0248368825 MG / VIALPOWDER FOR SOLUTION; KIT · INTRAVENOUSNOVADAQ TECHNOLOGIES ULC
SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT0252783925 MG / VIALKIT; POWDER FOR SOLUTION · INTRAVENOUSNOVADAQ TECHNOLOGIES ULC
SPY AGENT GREEN KIT FOR SPY ELITE0248366125 MG / VIALPOWDER FOR SOLUTION; KIT · INTRAVENOUSNOVADAQ TECHNOLOGIES ULC
SPY AGENT GREEN KIT FOR SPY-PHI0249867725 MG / VIALKIT; POWDER FOR SOLUTION · INTRADERMAL; INTRAVENOUS; INTERSTITIALNOVADAQ TECHNOLOGIES ULC
SPY AGENT GREEN LYMPHATICS KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT0248369625 MG / VIALKIT; POWDER FOR SOLUTION · INTERSTITIALNOVADAQ TECHNOLOGIES ULC

Safety signals and safety-related labeling changes

All safety entries for indocyanine green →

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.