| Code | 12663 | ||||||||||
| MA number | 44/0463/97-S | ||||||||||
| Product Form: | sol ijf 1x5 ml/10 mg (liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: | 
                
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous and intravesical use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10a well-established use application | 
| MA issued: | 23.10.1997 | 
| Pediatric indication: | Yes | 
| Pediatric posology: | Yes | 
| Pediatric warnings: | Yes | 
| SPC: | 
            
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| PIL: | 
            
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| Safety feature | Yes | 
| Data update: | 23.03.2021 |