Code | 9591E | ||||||||||
MA number | 41/0121/25-S | ||||||||||
Product Form: | con inf 1x5 ml/12,5 mg (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Pharmaselect International Beteiligungs GmbH, Austria | ||||||||||
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 restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 17.05.2025 |
Validity: | 17.05.2030 |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 20.05.2025 |