Drovelis

RSS

estetrol / drospirenone

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

Overview

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

This EPAR was last updated on 29/04/2022

Authorisation details

Product details
Name
Drovelis
Agency product number
EMEA/H/C/005336
Active substance
  • drospirenone
  • estetrol monohydrate
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
Gedeon Richter Plc.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
19/05/2021
Contact address

Gyomroi ut 19-21
1103 Budapest
Hungary

Product information

22/04/2022 Drovelis - EMEA/H/C/005336 - IB/0008

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

oral contraceptive

Assessment history

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