| Code | 9064E | ||||||||||
| MA number | 30/0211/24-S | ||||||||||
| Product Form: | tbl flm 28x5 mg (blis.PVC/PVdC//Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| 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: | 15.03.2025 |
| Validity: | 15.03.2030 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Irsamla_02.2025.pdf
|
| SPC: |
SPC_Irsamla tbl flm_05.2025.pdf
|
| Safety feature | Yes |
| Data update: | 28.05.2025 |
