| Code | 9680E | ||||||||
| MA number | EU/1/13/855/003 | ||||||||
| Product Form: | sus inj 10x0,5 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: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 29.04.2025 |
