| Code | 9641C | ||||||||||
| MA number | 65/0366/18-S | ||||||||||
| Product Form: | tbl plg 90x1x100 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_09.2021.pdf
|
| SPC: |
SPC_Tramadol Krka tablety s predĺženým uvoľňovaním_01.2022.pdf
|
| Safety feature | Yes |
| Data update: | 02.05.2023 |
