SAHPRA-2022-0078
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-078
Application Number
SAHPRA-2022-0078
Procedure Type
sMAA
Status
Active
Linked Product
Market Authorization
India · SAHPRA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-078 | eCTD | 7.0.2 | 5 | M1 (3), M2 (13), M3 (12), M4 (11), M5 (7) | Overdue |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query regarding bioequivalence study design | 2025-02-20 | medium | Open |
| Request for post-marketing commitment progress update | 2025-04-22 | low | In Progress |
| Request for additional clinical data on primary endpoint | 2024-12-11 | medium | Overdue |
| Request for post-marketing commitment progress update | 2025-03-10 | low | Open |
| Query: container closure integrity study methodology | 2025-04-20 | low | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide carcinogenicity study report for 2-year rat study | 2025-08-24 | low | Open |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-05-01 | medium | Open |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-10-08 | low | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-232 | SmPC | 12.4 | Approved |
| LBL-233 | IFU | 20.7 | Pending |
| LBL-234 | Labeling | 10.1 | Submitted |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SAHPRA-2022-0078-V078 | Type II | Completed | pending |
| SAHPRA-2022-0078-V178 | Type II | Pending | 2023-09-04 |
| SAHPRA-2022-0078-V278 | Type II | Pending | 2023-07-06 |
| SAHPRA-2022-0078-V378 | Minor | Approved | 2022-09-22 |
| SAHPRA-2022-0078-V478 | Type IA | Pending | 2023-09-22 |
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.