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PRODUCT DETAIL

Zafrilla 2 mg tablety

Code 2202D
MA number 56/0239/19-S
Product Form: tbl 84x2 mg (blis.PVC//Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU)
ATC:
G GENITO URINARY SYSTEM AND SEX HORMONES
G03 SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03D PROGESTOGENS
G03DB Pregnadien derivatives
G03DB08 Dienogest
Shelf life: 60
Container: blister PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 30.07.2019
Validity: 30.07.2024
MA renewed: Renewal application submitted
Pediatric posology: Yes
PIL: PIL_Zafrilla_10_2021.pdf  
SPC: SPC_Zafrilla_01_2023.pdf  
Safety feature Yes
Data update: 27.01.2023
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