Code | 5279E | ||||||||||
MA number | EU/1/17/1216/010 | ||||||||||
Product Form: | sol inj 1x0,4 ml/40 mg (striek.inj.napl.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: | 30 | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(4) similar biological application |
MA issued: | 24.08.2017 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 30.01.2024 |