Code | 52513 | ||||||||||
MA number | 68/0450/08-S | ||||||||||
Product Form: | cps dur 20x40 mg | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 08.09.2008 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
Dokument: | EPAR Zypsilan.doc |
PIL: | PIL_Zypsilan_08_2024.pdf |
SPC: | SPC_Zypsilan_08_2024.pdf |
Safety feature | Yes |
Data update: | 15.05.2018 |