| Code | 1917E | ||||||||||
| MA number | EU/1/22/1667/004 | ||||||||||
| Product Form: | con inf 10x16 ml/400 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: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 23.08.2022 |
