Lydisilka (estetrol;drospirenone)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- estetrol;drospirenone
- Company
- Estetra SPRL
- 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/005382
- ATC
- G03
- Official record
- www.ema.europa.eu
Indication
Oral contraception. The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Drovelis Authorised · Gedeon Richter Plc.
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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.