| Code | 4692E | ||||||||||
| MA number | EU/1/23/1747/001 | ||||||||||
| Product Form: | sol ijf 3x0,5 ml/10 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Jazz Pharmaceuticals Ireland Limited, Ireland | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intramuscular or intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 15.09.2023 |
| Validity: | 15.09.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 13.10.2023 |
