| Code | 7387C | ||||||||||
| MA number | 65/0107/18-S | ||||||||||
| Product Form: | sol ijf 25x1 ml/50 mg (amp.skl.) | ||||||||||
| 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: | 60 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Subcutaneous, intramuscular and intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 22.03.2018 |
| Pediatric posology: | Yes |
| SPC: |
SPC_Tramadol Krka injekčný-infúzny roztok_10.2024.pdf
|
| PIL: |
PIL_Tramadol Krka injekčný_infúzny roztok_10.2024.pdf
|
| Safety feature | Yes |
| Data update: | 19.07.2022 |
