This brand name is authorized in Austria, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom
The drug DROVELIS contains a combination of these active pharmaceutical ingredients (APIs):
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1
Drospirenone
UNII N295J34A25 - DROSPIRENONE
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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. |
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2
Estetrol
UNII KC3GI9UM9V - ESTETROL MONOHYDRATE
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Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| DROVELIS Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | 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 | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 7627-MEE-1122 |
| Country: EE | Ravimiamet | Identifier(s): 1849327, 1849338, 1849349, 1849350 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1211547001 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 533684 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 60689468 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 049524010, 049524022, 049524034, 049524046 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1092670, 1092671, 1092672, 1092673 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100453064 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W68086001, W68086002, W68086003, W68086004 |
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