| Code | 3589E | ||||||||||
| MA number | EU/1/23/1724/002 | ||||||||||
| Product Form: | con inf 5x10 ml/20 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Chiesi Farmaceutici S.p.A., Italy | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| 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: | 04.05.2023 |
| Validity: | 04.05.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Elfabrio_Príručka pre zdravotníckych pracovníkov.pdf
|
| Dokument: |
Elfabrio_Príručka pre pacientov.pdf
|
| Safety feature | Yes |
| Data update: | 01.10.2024 |
