DROVELIS

This brand name is authorized in Austria, Croatia, Ecuador, Estonia, Finland, France, Ireland, Italy, Lithuania, Poland, Romania, Spain, UK.

Active ingredients

The drug DROVELIS contains a combination of these active pharmaceutical ingredients (APIs):

1	Drospirenone UNII N295J34A25 - DROSPIRENONE
	Drospirenone is a progestogen. In a therapeutic dosage, drospirenone also possesses antiandrogenic and mild antimineralocorticoid properties. It has no estrogenic, glucocorticoid and antiglucocorticoid activity. This gives drospirenone a pharmacological profile closely resembling the natural hormone progesterone.
	Read more about Drospirenone
2	Estetrol UNII KC3GI9UM9V - ESTETROL MONOHYDRATE

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
DROVELIS Film-coated tablet	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
G03AA18		G Genito urinary system and sex hormones → G03 Sex hormones and modulators of the genital system → G03A Hormonal contraceptives for systemic use → G03AA Progestogens and estrogens, fixed combinations
Discover more medicines within G03AA18

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	7627-MEE-1122
EE	Ravimiamet	1849327, 1849338, 1849349, 1849350
ES	Centro de información online de medicamentos de la AEMPS	1211547001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	533684
FR	Base de données publique des médicaments	60689468
IT	Agenzia del Farmaco	049524010, 049524022, 049524034, 049524046
LT	Valstybinė vaistų kontrolės tarnyba	1092670, 1092671, 1092672, 1092673
PL	Rejestru Produktów Leczniczych	100453064
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W68086001, W68086002, W68086003, W68086004