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PRODUCT DETAIL

Amelgen

Code 3379C
MA number 56/0089/17-S
Product Form: glo vag 12x400 mg (strip PVC/PE)
MA Status: D - Marketing Authorisation valid for an unlimited period
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
G03DA Pregnen (4) derivatives
G03DA04 Progesterone
Shelf life: 48
Container: strip PVC/PE
Route of admin.: Vaginal use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 30.03.2017
SPC: SPC_Amelgen_06_2021.pdf  
PIL: PIL_Amelgen_06_2023.pdf  
Safety feature Yes
Data update: 22.10.2021
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