Code | 2469D | ||||||||||
MA number | 83/0286/19-S | ||||||||||
Product Form: | sol inf 1x10 ml (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
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 |
Validity: | 15.10.2024 |
MA renewed: | Renewal application submitted |
SPC: | SPC_Tresuvi 1 mg/ml infúzny roztok_08_2022.pdf |
PIL: | PIL_Tresuvi infúzny roztok_08_2022.pdf |
Safety feature | Yes |
Data update: | 18.10.2019 |