Code | 1916E | ||||||||||
MA number | EU/1/22/1667/003 | ||||||||||
Product Form: | con inf 10x4 ml/100 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Celltrion Healthcare Hungary Kft., Hungary | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | glass vial |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(4) similar biological application |
MA issued: | 17.08.2022 |
Validity: | 17.08.2027 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 16.05.2024 |