Code | 1741E | ||||||||||
MA number | EU/1/22/1653/001 | ||||||||||
Product Form: | sol inf 1x0,5 ml (liek.inj.skl.) | ||||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 45 | ||||||||||
Container: | glass vial |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 18.07.2022 |
Validity: | 18.07.2027 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 03.11.2023 |