Code | 4331E | ||||||||||
MA number | 19/0203/23-S | ||||||||||
Product Form: | sol inj 10x2 ml/200 mg (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Apta Medica Internacional d.o.o., Slovenia | ||||||||||
Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 18 | ||||||||||
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: | 20.09.2023 |
Validity: | 20.09.2028 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL Sugammadex AptaPharma 100 mg_ml injekčný roztok 09_2023.pdf |
SPC: | SPC Sugammadex AptaPharma 100 mg_ml injekčný roztok 09_2023.pdf |
Safety feature | Yes |
Data update: | 21.09.2023 |