| Code | 6911D | ||||||||||
| MA number | 01/0068/21-S | ||||||||||
| Product Form: | sol inj 5x20ml/50 mg (amp.PP v blistri) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 01 - ANAESTHETICA (LOKÁLNE) | ||||||||||
| ATC: | 
                
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| Shelf life: | 24 | ||||||||||
| Container: | ampoule PP | 
| Prescription Status: | Medicinal product subject to restricted medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 28.04.2021 | 
| Pediatric indication: | Yes | 
| Pediatric posology: | Yes | 
| Pediatric warnings: | Yes | 
| SPC: | 
            
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| PIL: | 
            
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| Safety feature | Yes | 
| Data update: | 28.05.2025 |