| Code | 8153E | ||||||||||
| MA number | 30/0314/24-S | ||||||||||
| Product Form: | tbl flm 98x20 mg (blis. PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Gedeon Richter Plc., Hungary | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 18 | ||||||||||
| 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: | 24.12.2024 | 
| Validity: | 24.12.2029 | 
| Pediatric warnings: | Yes | 
| SPC: |  | 
| PIL: |  | 
| Safety feature | Yes | 
| Data update: | 10.01.2025 |