Code | 3646D | ||||||||||
MA number | 56/0042/20-S | ||||||||||
Product Form: | gel tdm 1x80 g (fľ.PP s dávkovačom) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | bottle PP with dose dispenser | ||||||||||
Route of admin.: | Transdermal use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 04.03.2020 |
Validity: | 04.02.2025 |
MA renewed: | Renewal application submitted |
PIL: | PIL_Estradiol Besins_01_2024.pdf |
SPC: | SPC_Estradiol Besins_01_2024_opravene.pdf |
Safety feature | Yes |
Data update: | 06.03.2020 |