Drovelis

Gedeon Richter Plc.,Gyomroi ut 19-21,1103 Budapest,Hungary🇪🇺 European Union

EMA Page

Authorised Date: May 19, 2021
Approval ID: ed2e407b201dc576
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

Drovelis is a combined hormonal contraceptive. It contains the active substances drospirenone and estetrol monohydrate.

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication oral contraceptive

Therapeutic Area (MeSH)

Contraceptives, Oral

ATC Code

G03

ATC Item

性激素和生殖系统调节药

Pharmacotherapeutic Group

Sex hormones and modulators of the genital system

Active Substances

Active Substance (Summary)

drospirenoneestetrol monohydrate

INN / Common Names

estetroldrospirenone

Active Substance Details

Substance	CAS	Monograph
drospirenone	N/A	屈螺酮
estetrol monohydrate	N/A	Estetrol

Quick Info

Approval IDed2e407b201dc576

Product NumberN/A

StatusAuthorised

Authorised DateMay 19, 2021

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Drovelis

Medicine Name

Drovelis

Aliases

N/A

Regulatory Flags

Orphan medicineUnknown

Generic medicineUnknown

BiosimilarUnknown

Conditional approvalUnknown

Exceptional circumstancesUnknown

Accelerated assessmentUnknown

Additional monitoringUnknown

Advanced therapyUnknown

Source Links

EMA Source

No risk management plan link.

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