| Code | 4013E | ||||||||||
| MA number | 15/0168/23-S | ||||||||||
| Product Form: | sol ijf 25x6 ml/900 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: | 
                
  | 
        ||||||||||
| 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: | 
            
                 | 
    
| SPC: | 
            
                 | 
    
| Safety feature | Unknown | 
| Data update: | 25.05.2024 |