Code | 2028E | ||||||||||
MA number | 83/0247/22-S | ||||||||||
Product Form: | sol inf 1x20 ml/20 mg (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Reddy Holding GmbH, Germany | ||||||||||
Therapeutic Class: | 83 - VASODILATANTIA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
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: | 29.10.2022 |
Validity: | 29.10.2027 |
SPC: | SPC_Treprostinil Reddy 1 mg_ml infúzny roztok_09_2022.pdf |
PIL: | PIL_Treprostinil Reddy infúzny roztok_07_2024.pdf |
Safety feature | Yes |
Data update: | 04.11.2022 |