SAHPRA-2022-0038
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-038
Application Number
SAHPRA-2022-0038
Procedure Type
sBLA
Status
Submitted
Linked Product
Market Authorization
United Kingdom · SAHPRA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-038 | eCTD | 6.3.3 | 5 | M1 (7), M2 (8), M3 (4), M4 (15), M5 (9) | Draft |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for benefit-risk assessment addendum | 2025-01-02 | medium | Open |
| Request for post-marketing commitment progress update | 2025-01-04 | high | Open |
| Information request: manufacturing process change justification | 2025-04-14 | medium | In Progress |
| Request for post-marketing commitment progress update | 2025-01-28 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-09-19 | medium | Overdue |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-04-16 | medium | Blocked |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-09-25 | medium | Open |
| Update SmPC section 4.4 with hepatic impairment data | 2025-11-18 | high | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-112 | Labeling | 6.3 | Approved |
| LBL-113 | PIL | 20.7 | Approved |
| LBL-114 | Labeling | 18.3 | Active |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SAHPRA-2022-0038-V038 | Type IB | Completed | 2024-02-12 |
| SAHPRA-2022-0038-V138 | Major | Blocked | 2023-03-05 |
| SAHPRA-2022-0038-V238 | Type IA | Active | 2022-09-14 |
| SAHPRA-2022-0038-V338 | Type IB | Submitted | 2023-12-29 |
| SAHPRA-2022-0038-V438 | Major | Overdue | 2023-09-13 |
Inspection Readiness Risk Panel
Risk Score: 7 · Overdue commitments: 1, failed/blocked sequences: 2, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.