HSA-2023-0092
This application view consolidates identifiers, linked product and market authorization context, dossier structure, sequence history, and active authority obligations in one place. Regulatory teams use it to understand readiness and risk before publishing new sequences or responding to open questions. Cross-links to labeling and variations maintain lifecycle traceability for post-approval changes. Inspection readiness risk is calculated from overdue commitments, failed sequences, and unresolved high-risk correspondence for immediate action.
Application ID
APP-092
Application Number
HSA-2023-0092
Procedure Type
sBLA
Status
Failed
Linked Product
Market Authorization
European Union · HSA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-092 | NeeS | 3.4.1 | 5 | M1 (9), M2 (12), M3 (10), M4 (14), M5 (9) | Blocked |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: manufacturing process change justification | 2024-12-10 | medium | Draft |
| Deficiency: inadequate paediatric data justification | 2025-03-07 | low | Overdue |
| Request for updated SmPC section 4.1 | 2025-03-21 | low | Overdue |
| Information request: manufacturing process change justification | 2025-02-03 | low | Overdue |
| GMP inspection findings clarification | 2025-04-28 | medium | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Update SmPC section 4.4 with hepatic impairment data | 2025-04-22 | high | In Progress |
| Update SmPC section 4.4 with hepatic impairment data | 2025-11-20 | high | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-274 | SmPC | 17.1 | Active |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| HSA-2023-0092-V092 | Minor | Active | 2023-05-15 |
| HSA-2023-0092-V192 | Major | Failed | 2023-09-15 |
| HSA-2023-0092-V292 | Type II | In Progress | 2024-01-15 |
| HSA-2023-0092-V392 | Type IB | Overdue | 2022-09-07 |
| HSA-2023-0092-V492 | Type IB | Draft | 2022-11-15 |
Inspection Readiness Risk Panel
Risk Score: 2 · Overdue commitments: 0, failed/blocked sequences: 1, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.