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PRODUCT DETAIL

Zoely 2,5 mg/1,5 mg filmom obalené tablety

Code 4179A
MA number EU/1/11/690/004
Product Form: tbl flm 364 (312 akt.+52 placebo)x2,5 mg/1,5 mg (blis.PVC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Theramex Ireland Limited, Ireland
Therapeutic Class: 17 - ANTICONCIPIENTIA
ATC:
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
G03AA14 Nomegestrol and estradiol (Nomegestrol and estrogen-delete WHO)
Shelf life: 36
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10b fixed combination application
MA issued: 29.10.2012
SmPC + PL: European Medicines Agency's database
Dokument: Kombinovaná hormonálna antikoncepcia Informačná karta pre pacientku.pdf  
Dokument: Kombinovaná hormonálna antikoncepcia Kontrolný zoznam pre lekára.pdf  
Dokument: Kombinovaná hormonálna antikoncepcia Otázky a odpovede pre pacientky.pdf  
Safety feature Yes
Data update: 24.05.2021
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