Code | 4702E | ||||||||||
MA number | 19/0202/23-S | ||||||||||
Product Form: | sol inj 5x5 ml/500 mg (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Juta Pharma GmbH, Germany | ||||||||||
Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 20.10.2023 |
Validity: | 20.10.2028 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Sugammadex Juta_10_2023.pdf |
SPC: | SPC_Sugammadex Juta_10_2023.pdf |
Safety feature | Yes |
Data update: | 14.11.2023 |