SAHPRA-2022-0058
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-058
Application Number
SAHPRA-2022-0058
Procedure Type
sMAA
Status
Failed
Linked Product
Market Authorization
Austria · SAHPRA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-058 | NeeS | 6.8.7 | 5 | M1 (14), M2 (3), M3 (8), M4 (15), M5 (9) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query regarding bioequivalence study design | 2024-12-17 | high | In Progress |
| Request for updated SmPC section 4.1 | 2024-12-14 | medium | In Progress |
| Deficiency: inadequate paediatric data justification | 2024-12-24 | medium | Open |
| Query regarding bioequivalence study design | 2025-04-11 | medium | In Progress |
| Query: container closure integrity study methodology | 2025-01-30 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Validate analytical method for dissolution test per USP <711> | 2025-07-13 | medium | Overdue |
| Update SmPC section 4.4 with hepatic impairment data | 2024-11-19 | high | Overdue |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-12-11 | low | Blocked |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SAHPRA-2022-0058-V058 | Major | Draft | 2022-09-08 |
| SAHPRA-2022-0058-V158 | Type IB | Completed | 2022-11-20 |
| SAHPRA-2022-0058-V258 | Major | Completed | pending |
| SAHPRA-2022-0058-V358 | Type IB | Failed | 2023-09-12 |
| SAHPRA-2022-0058-V458 | Minor | Completed | 2024-03-25 |
Inspection Readiness Risk Panel
Risk Score: 7 · Overdue commitments: 2, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.