| Code | 9716C | ||||||||||
| MA number | 30/0298/18-S | ||||||||||
| Product Form: | tbl flm 100x25 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 26.11.2018 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Agomelatin_Mylan 25 mg_08.2021.pdf
|
| PIL: |
PIL_Agomelatine Mylan 25 mg_09.2022.pdf
|
| Safety feature | Yes |
| Data update: | 29.11.2023 |
