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Drovelis



Chemical Works Of Gedeon Richter PLCEU/1/21/1547/001-004

Main Information

Trade NameDrovelis
Active SubstancesDrospirenone
Estetrol
Estetrol monohydrate
Dosage FormFilm-coated tablet
Licence HolderChemical Works Of Gedeon Richter PLC
Licence NumberEU/1/21/1547/001-004

Group Information

ATC CodeG03AA Progestogens and estrogens, fixed combinations
G03AA18 Drospirenone and estetrol

Status

License statusAuthorised
Licence Issued19/05/2021
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

Educational Materials - Patient

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