Code | 4536E | ||||||||||
MA number | EU/1/23/1754/012 | ||||||||||
Product Form: | sol ira 12(3x4)x0,9 ml/162 mg (pero napl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Fresenius Kabi Deutschland GmbH, Germany | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(4) similar biological application |
MA issued: | 15.09.2023 |
Validity: | 15.09.2028 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 06.10.2023 |