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PRODUCT DETAIL

Tibolón Aristo 2,5 mg tablety

Code 1832D
MA number 54/0202/18-S
Product Form: tbl 1x30x2,5 mg (blis.PVC/PVDC/Al-kalendár.bal.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 54 - GYNAECOLOGICA
ATC:
G GENITO URINARY SYSTEM AND SEX HORMONES
G03 SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03C ESTROGENS
G03CX Other estrogens
G03CX01 Tibolone
Shelf life: 36
Container: blister PVC/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 21.06.2018
SPC: SPC_Tibolon Aristo_11_2023.pdf  
PIL: PIL_Tibolon Aristo_11_2023.pdf  
Safety feature Yes
Data update: 17.01.2023
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