Drovelis

estetrol / drospirenone

Table of contents

Opinion

On 25 March 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Drovelis, intended for oral contraception. The applicant for this medicinal product is Gedeon Richter Plc.

Drovelis will be available as 14.2 mg / 3 mg film-coated tablets. The active substances of Drovelis are estetrol (an oestrogen) and drospirenone (a progestogen) (ATC code: G03AA18). Estetrol is a new chemically synthesised oestrogen, which in humans is produced only by the liver of the human foetus during pregnancy and reaches the maternal circulation through the placenta. Estetrol suppresses follicle stimulating hormone activity and stabilises the bleeding pattern.  Drospirenone is a previously known progestogen, which suppresses luteinizing hormone activity. These actions result in a contraceptive effect which is based on the interaction of various factors, the most important of which is inhibition of ovulation.

The benefit of Drovelis is its ability to provide oral contraception. The most common side effects are metrorrhagia, headache, acne, vaginal haemorrhage and dysmenorrhoea.

The full indication is:

Oral contraception.

The decision to prescribe Drovelis should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Drovelis compares with other combined hormonal contraceptives (CHCs).

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Drovelis
Agency product number
EMEA/H/C/005336
International non-proprietary name (INN) or common name
  • estetrol
  • drospirenone
Active substance
  • drospirenone
  • estetrol monohydrate
Therapeutic area
Contraceptives, Oral
Date opinion adopted
25/03/2021
Company name
Gedeon Richter Plc.
Status
Positive
Application type
Initial authorisation

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