Code | 6380B | ||||||||||
MA number | 68/0435/15-S | ||||||||||
Product Form: | tbl 90x15 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 48 | ||||||||||
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: | 29.10.2015 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_ZYKALOR 15 mg_08 2022.pdf |
PIL: | PIL_ZYKALOR 15 mg_08 2022.pdf |
Safety feature | Yes |
Data update: | 13.02.2020 |