Drovelis Gedeon Richter Plc. · Authorised · authorised 19 May 2021 · ATC G03
Therapeutic indication (EMA)
oral contraceptive
Active substances
Drospirenone + Estetrol
- US FDA 1
- EMA 2
- Health Canada 1
- US price lines 1
- NHS prices 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| NEXTSTELLIS | 3MG;14.2MG | tablet · oral | MAYNE PHARMA | Prescription | 15 Apr 2021 |
EMA European Union — centrally authorised medicines
Lydisilka Estetra SPRL · Authorised · authorised 19 May 2021 · ATC G03
Therapeutic indication (EMA)
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).
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| NEXTSTELLIS | 02513218 | 3 MG; 15 MG | TABLET · ORAL | SEARCHLIGHT PHARMA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | NEXTSTELLIS 3-14.2 MG TABLET | $7.66753 | per EA | 1 Jun 2026 |
| NHS Drug Tariff | Drospirenone 3mg / Estetrol 14.2mg tablets | £8.60 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Components
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.