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PRODUCT DETAIL

Esmya 5 mg tablety

Code 0086A
MA number EU/1/12/750/001
Product Form: tbl 28x5 mg (blis.PVC/PE/PVDC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 54 - GYNAECOLOGICA
ATC:
G GENITO URINARY SYSTEM AND SEX HORMONES
G03 SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03X OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03XB Progesterone receptor modulators
G03XB02 Ulipristal
Shelf life: 36
Container: blister PVC/PE/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 23.02.2012
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 22.02.2021
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