Drovelis (estetrol;drospirenone)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- estetrol;drospirenone
- Company
- Gedeon Richter Plc.
- Status
- Authorised
- Therapeutic area
- Contraceptives, Oral
- CHMP opinion
- Thu 25 Mar 2021
- EU approval
- Wed 19 May 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005336
- ATC
- G03
- Official record
- www.ema.europa.eu
Indication
oral contraceptive
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Lydisilka Authorised · Estetra SPRL
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.