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 | ||||||||||
MAH, country: | Gedeon Richter Plc., Hungary | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
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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 |