EMA-2023-0062
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-062
Application Number
EMA-2023-0062
Procedure Type
Label Update
Status
Failed
Linked Product
Market Authorization
European Union · EMA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-062 | CTD | 5.5.0 | 5 | M1 (6), M2 (8), M3 (9), M4 (9), M5 (4) | Draft |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency letter: missing stability data for 40°C condition | 2025-01-31 | high | In Progress |
| GMP inspection findings clarification | 2025-03-02 | high | Overdue |
| Query: container closure integrity study methodology | 2025-02-12 | medium | Open |
| Question on comparative dissolution data | 2025-04-14 | medium | Open |
| Query: container closure integrity study methodology | 2025-02-25 | medium | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-05-04 | medium | Overdue |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-01-31 | medium | Open |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-09-13 | high | Blocked |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-09-21 | high | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-184 | SmPC | 17.5 | Pending |
| LBL-185 | Labeling | 1.2 | Submitted |
| LBL-186 | IFU | 16.0 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| EMA-2023-0062-V062 | Type IB | In Progress | 2024-04-09 |
| EMA-2023-0062-V162 | Major | Pending | 2024-03-11 |
| EMA-2023-0062-V262 | Type II | Blocked | 2023-05-15 |
| EMA-2023-0062-V362 | Major | Approved | 2024-05-24 |
| EMA-2023-0062-V462 | Type IA | Pending | 2022-08-02 |
Inspection Readiness Risk Panel
Risk Score: 8 · Overdue commitments: 1, failed/blocked sequences: 2, high-risk questions: 2.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.