Active substance
Dienestrol
- US FDA 4
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DIENESTROL | 0.01% | cream · vaginal | ORTHO MCNEIL PHARM | Discontinued | 9 Jan 1947 |
| ESTRAGUARD | 0.01% | cream · vaginal | SOLVAY | Discontinued | 4 Nov 1975 |
| DV | 0.7MG | suppository · vaginal | SANOFI AVENTIS US | Discontinued | |
| DV | 0.01% | cream · vaginal | SANOFI AVENTIS US | Discontinued |
Safety signals and safety-related labeling changes
- EMA PRAC 14 May 2020 PRAC signal: New information on the known risk of breast cancer
Action for MAH: update of the product information: Yes - EMA PRAC 12 Mar 2020 PRAC signal: New information on the known risk of breast cancer
Action for MAH: update of the product information: No - EMA PRAC 16 Jan 2020 PRAC signal: New information on the known risk of breast cancer
Action for MAH: update of the product information: No - EMA PRAC 3 Oct 2019 PRAC signal: New information on the known risk of breast cancer
Action for MAH: update of the product information: No
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.