HSA-2023-0012
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-012
Application Number
HSA-2023-0012
Procedure Type
sNDA
Status
In Progress
Linked Product
Market Authorization
Italy · HSA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-012 | CTD | 1.7.7 | 5 | M1 (15), M2 (5), M3 (13), M4 (12), M5 (8) | Draft |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for updated SmPC section 4.1 | 2025-01-17 | high | In Progress |
| Request for updated SmPC section 4.1 | 2025-04-04 | low | Open |
| Request for benefit-risk assessment addendum | 2025-02-07 | medium | Draft |
| Request for post-marketing commitment progress update | 2025-02-10 | medium | Overdue |
| GMP inspection findings clarification | 2025-03-20 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-02-17 | low | Blocked |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-04-14 | medium | Overdue |
| Submit harmonised global label per ICH Q12 PLCR | 2025-11-30 | low | Open |
| Update SmPC section 4.4 with hepatic impairment data | 2025-07-02 | high | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-034 | IFU | 1.9 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| HSA-2023-0012-V012 | Type IA | Overdue | pending |
| HSA-2023-0012-V112 | Type II | Pending | 2024-02-08 |
| HSA-2023-0012-V212 | Type IA | Submitted | pending |
| HSA-2023-0012-V312 | Type IB | In Progress | 2023-12-09 |
| HSA-2023-0012-V412 | Type II | Submitted | 2023-09-20 |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.