| Code | 3983B | ||||||||||
| MA number | 42/0154/15-S | ||||||||||
| Product Form: | sol inf 5x100 ml/500 mg (liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
| ATC: | 
                
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 22.04.2015 | 
| Pediatric contraindication: | Yes | 
| Pediatric warnings: | Yes | 
| PIL: | 
            
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| SPC: | 
            
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| Safety feature | Yes | 
| Data update: | 30.12.2019 |