| Code | 9498C | ||||||||||
| MA number | 30/0348/18-S | ||||||||||
| Product Form: | tbl flm 10x25 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
| 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: | 19.10.2018 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Agomelatine G.L. Pharma_október_2018.docx
|
| PIL: |
PIL_Agomelatine G.L. Pharma _október_2018.docx
|
| Safety feature | Yes |
| Data update: | 23.12.2022 |
