EMA-2023-0042
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-042
Application Number
EMA-2023-0042
Procedure Type
NDS
Status
Blocked
Linked Product
Market Authorization
Italy · EMA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-042 | eCTD | 8.9.5 | 5 | M1 (15), M2 (13), M3 (14), M4 (10), M5 (7) | Blocked |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| GMP inspection findings clarification | 2025-04-22 | low | Draft |
| Question on comparative dissolution data | 2025-05-06 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide carcinogenicity study report for 2-year rat study | 2025-07-27 | low | Blocked |
| Update SmPC section 4.4 with hepatic impairment data | 2025-02-23 | medium | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-124 | PIL | 8.3 | Submitted |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| EMA-2023-0042-V042 | Type IA | Completed | 2024-02-04 |
| EMA-2023-0042-V142 | Type IB | Active | pending |
| EMA-2023-0042-V242 | Type IA | Blocked | 2023-05-15 |
| EMA-2023-0042-V342 | Type IB | Submitted | pending |
| EMA-2023-0042-V442 | Type IA | Pending | pending |
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.