| Code | 3691E | ||||||||||
| MA number | EU/1/23/1735/001 | ||||||||||
| Product Form: | con inf 1x30 ml/300 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Samsung Bioepis NL B.V., Netherland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(4) similar biological application |
| MA issued: | 26.05.2023 |
| Validity: | 26.05.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 02.06.2023 |
