| Code | 0122F | ||||||||||
| MA number | 08/0154/25-S | ||||||||||
| Product Form: | cps mdd 14x3,75 mg/23 mg (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Vivus B.V., Netherland | ||||||||||
| Therapeutic Class: | 08 - ANOREXICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 17.06.2025 |
| Validity: | 17.06.2030 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Qsiva_05 2025.pdf
|
| PIL: |
PIL_Qsiva_05 2025.pdf
|
| Safety feature | Yes |
| Data update: | 24.06.2025 |
