| Code | 0129F | ||||||||
| MA number | 08/0157/25-S | ||||||||
| Product Form: | cps mdd 30x15 mg/92 mg (fľ.HDPE) | ||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
| 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 |
| SPC: |
SPC_Qsiva cps mdd_09.2025.pdf
|
| PIL: |
PIL_Qsiva cps mdd_09.2025.pdf
|
| Dokument: |
Qsiva_HCP_Guide_Checklist_SK_Sept2025.pdf
|
| Dokument: |
Qsiva_Patient_Guide_SK_Sept2025.pdf
|
| Safety feature | Yes |
| Data update: | 31.07.2025 |
