Drovelis
estetrol / drospirenone
Table of contents
Overview
Drovelis is a combined hormonal contraceptive. It contains the active substances drospirenone and estetrol monohydrate.
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Drovelis : EPAR - Medicine overview (PDF/109.31 KB)
First published: 02/06/2021
EMA/196734/2021 -
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Drovelis : EPAR - Risk-management-plan summary (PDF/101.47 KB)
First published: 02/06/2021
Last updated: 14/03/2023
Authorisation details
Product details | |
---|---|
Name |
Drovelis
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Agency product number |
EMEA/H/C/005336
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Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Contraceptives, Oral
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Anatomical therapeutic chemical (ATC) code |
G03
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Publication details | |
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Marketing-authorisation holder |
Gedeon Richter Plc.
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Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
19/05/2021
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Contact address |
Gyomroi ut 19-21 |
Product information
30/03/2023 Drovelis - EMEA/H/C/005336 - IB/0018
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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