| Code | 2510F | ||||||||||
| MA number | 30/0021/26-S | ||||||||||
| Product Form: | tbl flm 30x10 mg (blis.PVC/PVDC/Al - neperfor.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| 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: | 30.01.2026 |
| Validity: | 31.01.2031 |
| Pediatric warnings: | Yes |
| SPC: |
|
| PIL: |
|
| Safety feature | Yes |
| Data update: | 04.02.2026 |