| Code | 2469D | ||||||||||
| MA number | 83/0286/19-S | ||||||||||
| Product Form: | sol inf 1x10 ml (liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Amomed Pharma GmbH, Austria | ||||||||||
| Therapeutic Class: | 83 - VASODILATANTIA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous and intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 15.10.2019 |
| SPC: |
SPC_Tresuvi 1 mg/ml infúzny roztok_sol inf_09_2024.pdf
|
| PIL: |
PIL_Tresuvi infúzny roztok_09_2024.pdf
|
| Dokument: |
Tresuvi_Príručka pre pacienta o používaní infúzneho systému.pdf
|
| Dokument: |
Tresuvi_Školenie pre zdravotníckych pracovníkov o bezpečnom zaobchádzaní s i.v. liekom.pdf
|
| Dokument: |
Tresuvi_Dotazník pre pacienta.pdf
|
| Dokument: |
Tresuvi_Formulár na hlásenie nežiaduceho účinku spojeného s infekciou krvného riečiska.pdf
|
| Safety feature | Yes |
| Data update: | 22.11.2024 |
