HSA-2023-0072
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-072
Application Number
HSA-2023-0072
Procedure Type
MAA
Status
Failed
Linked Product
Market Authorization
Italy · HSA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-072 | CTD | 1.5.0 | 5 | M1 (5), M2 (11), M3 (14), M4 (8), M5 (7) | Completed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2025-02-06 | medium | In Progress |
| Request for post-marketing commitment progress update | 2025-03-26 | medium | In Progress |
| Request for benefit-risk assessment addendum | 2025-01-04 | high | Open |
| Deficiency: inadequate paediatric data justification | 2024-12-26 | medium | In Progress |
| Request for post-marketing commitment progress update | 2025-02-01 | high | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Validate analytical method for dissolution test per USP <711> | 2024-11-09 | high | Blocked |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-09-15 | high | In Progress |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-02-28 | medium | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-214 | Labeling | 17.5 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| HSA-2023-0072-V072 | Type II | Blocked | 2023-06-21 |
| HSA-2023-0072-V172 | Type IA | In Progress | 2022-08-21 |
| HSA-2023-0072-V272 | Type IB | Blocked | 2022-12-09 |
| HSA-2023-0072-V372 | Type IA | Overdue | 2023-01-04 |
| HSA-2023-0072-V472 | Type IA | Blocked | pending |
Inspection Readiness Risk Panel
Risk Score: 6 · Overdue commitments: 0, failed/blocked sequences: 2, high-risk questions: 2.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.