CDSCO-2022-0073
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-073
Application Number
CDSCO-2022-0073
Procedure Type
MAA
Status
Overdue
Linked Product
Market Authorization
Spain · CDSCO
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-073 | eCTD | 8.2.8 | 5 | M1 (10), M2 (15), M3 (3), M4 (12), M5 (10) | Draft |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for updated SmPC section 4.1 | 2025-03-07 | medium | In Progress |
| Deficiency letter: missing stability data for 40°C condition | 2025-01-10 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-02-20 | low | Overdue |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-03-28 | low | Open |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-04-02 | high | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-217 | SmPC | 15.7 | In Progress |
| LBL-218 | SmPC | 6.3 | Active |
| LBL-219 | PIL | 18.6 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| CDSCO-2022-0073-V073 | Type IA | Pending | pending |
| CDSCO-2022-0073-V173 | Type II | Active | pending |
| CDSCO-2022-0073-V273 | Minor | Draft | 2023-08-29 |
| CDSCO-2022-0073-V373 | Major | Pending | 2023-04-06 |
| CDSCO-2022-0073-V473 | Major | Completed | pending |
Inspection Readiness Risk Panel
Risk Score: 2 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.