Active substance
Polidocanol
- US FDA 3
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ASCLERA | 10MG/2ML (5MG/ML); 20MG/2ML (10MG/ML) | solution · intravenous | CHEMISCH FBRK KRSSLR | Prescription | 30 Mar 2010 |
| VARITHENA | 180MG/18ML (10MG/ML) | solution · intravenous | BOSTON SCITFC | Prescription | 25 Nov 2013 |
| VARITHENA | 77.5MG/7.75ML (10MG/ML) | solution · intravenous | BOSTON SCITFC | Discontinued | 25 Nov 2013 |
Safety signals and safety-related labeling changes
- US FDA 29 Aug 2019 ASCLERA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations - US FDA 21 Aug 2019 VARITHENA — safety-related labeling change
Labeling sections changed: Use in Specific Populations
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.