The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Zoely



Theramex Ireland LimitedEU/1/11/690/001-002

Main Information

Trade NameZoely
Active SubstancesNOMEGESTROL ACETATE
Estradiol hemihydrate
Dosage FormFilm-coated tablet
Licence HolderTheramex Ireland Limited
Licence NumberEU/1/11/690/001-002

Group Information

ATC CodeG03AA Progestogens and estrogens, fixed combinations
G03AA14 nomegestrol and estradiol

Status

License statusAuthorised
Licence Issued27/07/2011
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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