| Code | 6658E | ||||||||||
| MA number | EU/1/24/1804/002 | ||||||||||
| Product Form: | sol inf 1x50 ml/225 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | BrePco Biopharma Ltd., United Kingdom | ||||||||||
| Therapeutic Class: | 41 - CARDIACA | ||||||||||
| ATC: | 
                
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10a well-established use application | 
| MA issued: | 27.05.2024 | 
| Validity: | 27.05.2029 | 
| SmPC + PL: | 
                                                 | 
                
| Safety feature | Yes | 
| Data update: | 24.06.2024 |