European Medicines Agency Pre-Authorisation Procedural Advice
Guidance on procedural advice for users of the centralised procedure by the European Medicines Agency.
Drug profile · INN
DIENESTROL
dienestrol (DIENESTROL) is a estrogen receptor alpha agonist. Route of administration: vaginal. Current US regulatory status: approved.
dienestrol (DIENESTROL) is a estrogen receptor alpha agonist. Route of administration: vaginal. Current US regulatory status: approved.
Estrogen receptor alpha agonist
Primary target: Estrogen receptor
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
dienestrol (DIENESTROL) is a estrogen receptor alpha agonist. Route of administration: vaginal. Current US regulatory status: approved.
DIENESTROL is a marketed brand name for dienestrol. Check FDA Drugs@FDA for the current US label holder and prescribing information.
dienestrol has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.