| Code | 9442B | ||||||||||
| MA number | 68/0256/16-S | ||||||||||
| Product Form: | tbl plg 60x300 mg (fľ.HDPE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 23.05.2016 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Hedonin XR_11 2023.pdf
|
| PIL: |
PIL_Hedonin XR_11 2023.pdf
|
| Safety feature | Yes |
| Data update: | 26.11.2020 |
