| Code | 8299C | ||||||||||
| MA number | 54/0202/18-S | ||||||||||
| Product Form: | tbl 3x28x2,5 mg (blis.PVC/PVDC/Al-kalendár.bal.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Aristo Pharma GmbH, Germany | ||||||||||
| Therapeutic Class: | 54 - GYNAECOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 21.06.2018 |
| SPC: |
SPC_Tibolon Aristo_09_2025.pdf
|
| PIL: |
PIL_Tibolon Aristo_09_2025.pdf
|
| Safety feature | Yes |
| Data update: | 17.01.2023 |
