Code | 6777A | ||||||||
MA number | EU/1/13/855/001 | ||||||||
Product Form: | sus inj 20x0,5 ml (liek.inj.skl) | ||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||
Type of procedure: | EU | ||||||||
MAH, country: | Bavarian Nordic A/S, Denmark | ||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||
ATC: |
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Shelf life: | 36 | ||||||||
Container: | glass vial | ||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 31.07.2013 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 16.10.2023 |