| Code | 2796B | ||||||||||
| MA number | 68/0033/15-S | ||||||||||
| Product Form: | tbl plg 60x150 mg (blis.PVC/PCTFE/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PCTFE/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 29.01.2015 |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Ketilept Prolong_06_2024.pdf
|
| PIL: |
PIL_Ketilept Prolong 06_2024.docx
|
| Safety feature | Yes |
| Data update: | 27.04.2020 |
