| Code | 4516C | ||||||||||
| MA number | 68/0180/17-S | ||||||||||
| Product Form: | tablety 50x100 mg (blis.Al/PVC/PVDC) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Accord Healthcare Polska Sp. z o.o., Poland | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister Al/PVC/PVDC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 23.06.2017 |
| SPC: |
SPC_Clozapine Accord_06_2023.pdf
|
| PIL: |
PIL_Clozapine Accord_10_2024.pdf
|
| Dokument: |
DHPC_Klozapín_08.09.2025.pdf
|
| Safety feature | Yes |
| Data update: | 03.08.2023 |
