Lydisilka

RSS

estetrol / drospirenone

Authorised
This medicine is authorised for use in the European Union.

Overview

Lydisilka is a combined hormonal contraceptive. It contains the active substances drospirenone and estetrol monohydrate.

This EPAR was last updated on 02/06/2021

Authorisation details

Product details
Name
Lydisilka
Agency product number
EMEA/H/C/005382
Active substance
  • estetrol monohydrate
  • drospirenone
International non-proprietary name (INN) or common name
  • estetrol
  • drospirenone
Therapeutic area (MeSH)
Contraceptives, Oral
Anatomical therapeutic chemical (ATC) code
G03
Publication details
Marketing-authorisation holder
Estetra SPRL
Date of issue of marketing authorisation valid throughout the European Union
19/05/2021
Contact address

Rue Saint-Georges 5
4000 Liege
Belgium

Product information

19/05/2021 Lydisilka - EMEA/H/C/005382 -

Contents

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Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic 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).

Assessment history

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