Active substance
Estrone
- US FDA 5
- Health Canada 1
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| THEELIN | 1MG/ML; 2MG/ML; 5MG/ML | injectable · injection | PARKEDALE | Discontinued | 12 Jun 1941 |
| ESTRONE | 5MG/ML | injectable · injection | DR REDDYS | Discontinued | 21 Feb 1979 |
| ESTRONE | 2MG/ML | injectable · injection | WATSON LABS | Discontinued | |
| ESTROGENIC SUBSTANCE | 2MG/ML | injectable · injection | WYETH AYERST | Discontinued | |
| NATURAL ESTROGENIC SUBSTANCE-ESTRONE | 2MG/ML | injectable · injection | WATSON LABS | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ESTRAGYN VAGINAL CREAM | 00727369 | 0.1 % / W/W | CREAM · VAGINAL | SEARCHLIGHT PHARMA INC |
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.