| Code | 7528D | ||||||||||
| MA number | 56/0133/21-S | ||||||||||
| Product Form: | cps vam 15x300 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: |
|
||||||||||
| 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: | 09.06.2021 |
| Validity: | 09.06.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Utrogestan 300 mg_09_2024.pdf
|
| PIL: |
PIL_Utrogestan 300mg_09_2024.pdf
|
| Safety feature | Yes |
| Data update: | 23.06.2021 |
