| Code | 2963F |
| MA number | EU/1/25/2002/001 |
| Product Form: | con ivs 1x0,4 ml/400 µg (liek.inj.skl.) |
| MA Status: | Ex - Conditional centralised marketing authorisation |
| Type of procedure: | EU |
| MAH, country: | ImmunityBio Ireland Limited, Ireland |
| Shelf life: | 36 |
| Container: | glass vial |
| Route of admin.: | Intravesical use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 16.02.2026 |
| Validity: | 16.02.2027 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 12.03.2026 |
