Active substance
Aminolevulinic acid
- US FDA 3
- Health Canada 2
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| GLEOLAN | 02504928 | 1.5 G / VIAL | POWDER FOR SOLUTION · ORAL | MEDEXUS PHARMACEUTICALS INC. |
| LEVULAN KERASTICK | 02243933 | 20 % / W/V | POWDER FOR SOLUTION · TOPICAL | SUN PHARMACEUTICAL INDUSTRIES, INC. |
Safety signals and safety-related labeling changes
- US FDA 9 Sep 2026 AMELUZ — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 May 2022 LEVULAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2019 GLEOLAN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; 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.