Code | 9021D | ||||||||||
MA number | EU/1/18/1319/011 | ||||||||||
Product Form: | sol inj 1x0,8 ml/40 mg (striek.inj.napl.plast.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Biosimilar Collaborations Ireland Limited, Ireland | ||||||||||
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: | 17.09.2018 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 09.08.2023 |