| Code | 0363E | ||||||||||
| MA number | EU/1/22/1630/001 | ||||||||||
| Product Form: | con inf 1x0,5 ml/100 µg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Immunocore Ireland Limited, Ireland | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: | 
                
  | 
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use | 
| Prescription Status: | Medicinal product subject to restricted medical prescription. | 
| Legal basis: | Article 8(3) application - new active substance | 
| MA issued: | 01.04.2022 | 
| Validity: | 01.04.2027 | 
| SmPC + PL: | 
                                                 | 
                
| Safety feature | Yes | 
| Data update: | 21.05.2025 |