Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
Drovelis 3 mg/14.2 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). The active film-coated tablet is pink, 6 mm diameter, round, biconvex with a drop-shaped logo embossed on one side. The placebo film-coated tablet is white to off-white, 6 mm diameter, round, biconvex with a drop-shaped logo embossed on one side. |
Each pink active tablet contains 3 mg drospirenone and estetrol monohydrate equivalent to 14.2 mg estetrol.
Each white placebo tablet does not contain active substances.
Excipient with known effect:
Each pink active tablet contains 40 mg lactose monohydrate.
Each white placebo tablet contains 68 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
|
| Drospirenone and Estetrol |
Estetrol demonstrates anti-gonadotropic activity characterised by a dose-dependent decrease in both serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels. The progestogen drospirenone possesses progestagenic, antigonadotropic, antiandrogenic and mild antimineralocorticoid properties and has no oestrogenic, glucocorticoid or antiglucocorticoid activity. These properties are pharmacologically similar to the natural hormone progesterone. The contraceptive effect of drospirenone/estetrol is based on the interaction of various factors, the most important of which is inhibition of ovulation. |
| List of Excipients |
|---|
Pink active film-coated tabletsTablet core: Lactose monohydrate Tablet coating: Hypromellose (E464) White placebo film-coated tabletsTablet core: Lactose monohydrate Tablet coating: Hypromellose (E464) |
Transparent PVC/aluminium blister containing 28 film-coated tablets (24 pink active tablets and 4 white placebo tablets) in a carton with an etui storage bag and 1, 3, 6 or 13 self-adhesive weekday sticker(s).
Pack sizes: 28 (1 × 28), 84 (3 × 28), 168 (6 × 28) and 364 (13 × 28) film-coated tablets.
Not all pack sizes may be marketed.
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
EU/1/21/1547/001
EU/1/21/1547/002
EU/1/21/1547/003
EU/1/21/1547/004
Date of first authorisation: 19 May 2021
| Drug | Countries | |
|---|---|---|
| DROVELIS | Austria, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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