| Code | 52535 | ||||||||||
| MA number | 68/0452/08-S | ||||||||||
| Product Form: | cps dur 56x80 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 |
