Code | 44645 | ||||||||||
MA number | 68/0183/02-S | ||||||||||
Product Form: | cps dur 30x80 mg (blis.Al/PVC/PVA) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
MAH, country: | Upjohn EESV, Netherland | ||||||||||
Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | blister Al/PVC/PA/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 11.09.2002 |
Pediatric warnings: | Yes |
SPC: | SPC_ZELDOX_11_2022.pdf |
PIL: | PIL_ZELDOX_11_2022.pdf |
Safety feature | Yes |
Data update: | 24.08.2018 |