Active substance
Riboflavin 5
- US FDA 3
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA | EQ 0.146% BASE/ML;EQ 0.146% BASE/ML | solution/drops · ophthalmic | GLAUKOS | Prescription | 15 Apr 2016 |
| PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | solution/drops · ophthalmic | GLAUKOS | Prescription | 15 Apr 2016 |
| EPIOXA HD/EPIOXA KIT | EQ 0.239% BASE/ML;EQ 0.177% BASE/ML | solution/drops · ophthalmic | GLAUKOS | Prescription | 17 Oct 2025 |
Safety signals and safety-related labeling changes
- US FDA 6 Nov 2024 INFUVITE ADULT — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 16 Dec 2020 M.V.I. ADULT — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Nov 2017 M.V.I. ADULT (PHARMACY BULK PACKAGE) — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Nov 2017 M.V.I.-12 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.