| Code | 3380C | ||||||||||
| MA number | 56/0089/17-S | ||||||||||
| Product Form: | glo vag 15x400 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 |
