EMA-2023-0082
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-082
Application Number
EMA-2023-0082
Procedure Type
NDA
Status
Blocked
Linked Product
Market Authorization
Saudi Arabia · EMA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-082 | NeeS | 7.2.1 | 5 | M1 (9), M2 (14), M3 (14), M4 (6), M5 (10) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for benefit-risk assessment addendum | 2025-04-07 | high | Open |
| GMP inspection findings clarification | 2025-02-22 | low | Draft |
| Request for benefit-risk assessment addendum | 2024-12-19 | medium | Open |
| Query regarding bioequivalence study design | 2025-02-23 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-02-18 | high | Open |
| Update SmPC section 4.4 with hepatic impairment data | 2025-06-25 | medium | In Progress |
| Complete Phase IV post-marketing observational study (n=500) | 2025-02-15 | high | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-244 | Labeling | 5.2 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| EMA-2023-0082-V082 | Type IA | Active | pending |
| EMA-2023-0082-V182 | Type IA | Active | 2024-03-11 |
| EMA-2023-0082-V282 | Type II | Blocked | pending |
| EMA-2023-0082-V382 | Type IB | Draft | 2023-11-02 |
| EMA-2023-0082-V482 | Type IB | Overdue | 2022-07-21 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 0, failed/blocked sequences: 2, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.