| Code | 1712E | ||||||||||
| MA number | 19/0210/22-S | ||||||||||
| Product Form: | sol inj 1x5 ml/500 mg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Reddy Holding 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: | 27.08.2022 |
| Validity: | 27.08.2027 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Sugammadex Ready 100 mg_ml injekčný roztok_05_2024.pdf
|
| SPC: |
SPC_Sugammadex Reddy 100 mg_ml injekčný roztok_02_2025.pdf
|
| Safety feature | Yes |
| Data update: | 06.09.2022 |
