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: |
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Safety feature | Yes |
Data update: | 24.06.2024 |