Code | 9651C | ||||||||||
MA number | 65/0367/18-S | ||||||||||
Product Form: | tbl plg 10x1x150 mg (blis.PVC/PVDC/papier/Al-jednotliv.dáv.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PVDC/paper/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 15.11.2018 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Tramadol Krka tablety s predĺženým uvoľňovaním_10.2024.pdf |
SPC: | SPC_Tramadol Krka tablety s predĺženým uvoľňovaním_10.2024.pdf |
Safety feature | Yes |
Data update: | 02.05.2023 |