| Code | 8543C | ||||||||||
| MA number | 30/0260/18-S | ||||||||||
| Product Form: | tbl flm 28x25 mg (blis.OPA/Al/PE/vysušovadlo/Al/PE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 18 | ||||||||||
| Container: | blister OPA/Al/PE/desiccant/Al/PE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 17.08.2018 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Agomelatín Teva_07.2021.pdf
|
| SPC: |
SPC_Agomelatín Teva_04.2022.pdf
|
| Safety feature | Yes |
| Data update: | 21.11.2022 |
