Code | 4007E | ||||||||||
MA number | 15/0168/23-S | ||||||||||
Product Form: | sol ijf 5x4 ml/600 mg (amp.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | glass ampoule |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 14.07.2023 |
Validity: | 14.07.2028 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Clindamycin Noridem 150 mg_ml injekčný_infúzny roztok_07 2023.pdf |
SPC: | SPC_Clindamycin Noridem 150 mg_ml injekčný_infúzny roztok_05.2024.pdf |
Safety feature | Unknown |
Data update: | 25.05.2024 |