| Code | 8127A | ||||||||||
| MA number | 30/0482/06-S | ||||||||||
| Product Form: | tbl 100x20 mg (blis.PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.11.2006 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_ARKETIS_02.2024.pdf
|
| SPC: |
SPC_ARKETIS_02.2024.pdf
|
| Safety feature | Yes |
| Data update: | 23.05.2019 |
