Code | 8737A | ||||||||||
MA number | 30/0430/10-S | ||||||||||
Product Form: | tbl flm 56x100 mg (blis.Al/PVC) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Upjohn EESV, Netherland | ||||||||||
Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Container: | blister Al/PVC | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 16.01.1996 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_ZOLOFT 50 mg_100 mg_04.2024.pdf |
PIL: | PIL_ZOLOFT 50 mg_100 mg_04.2024.pdf |
Safety feature | Yes |
Data update: | 07.03.2019 |