| Code | 0628F | ||||||||||
| MA number | 56/0238/25-S | ||||||||||
| Product Form: | cps vam 15x400 mg (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Besins Healthcare Ireland Limited, Ireland | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Vaginal use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 06.08.2025 |
| Validity: | 06.08.2030 |
| SPC: |
SPC_Utrogestan 400 mg_08_2025.pdf
|
| PIL: |
PIL_Utrogestan 400 mg_08_2025.pdf
|
| Safety feature | Yes |
| Data update: | 08.08.2025 |
