MOH-IL-2020-0040
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-040
Application Number
MOH-IL-2020-0040
Procedure Type
BLA
Status
Failed
Linked Product
Market Authorization
Germany · MOH-IL
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-040 | NeeS | 7.0.6 | 5 | M1 (9), M2 (8), M3 (6), M4 (5), M5 (9) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for benefit-risk assessment addendum | 2025-02-17 | high | Open |
| Question on comparative dissolution data | 2024-12-22 | low | Overdue |
| Information request: manufacturing process change justification | 2025-03-01 | low | Overdue |
| Deficiency: inadequate paediatric data justification | 2025-04-30 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Update SmPC section 4.4 with hepatic impairment data | 2024-12-28 | high | In Progress |
| Validate analytical method for dissolution test per USP <711> | 2025-02-20 | low | Open |
| Complete Phase IV post-marketing observational study (n=500) | 2025-03-23 | medium | Overdue |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2024-11-10 | medium | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-118 | PIL | 15.1 | In Progress |
| LBL-119 | IFU | 4.5 | Approved |
| LBL-120 | Labeling | 6.5 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MOH-IL-2020-0040-V040 | Minor | Submitted | 2023-04-24 |
| MOH-IL-2020-0040-V140 | Type IB | Active | 2023-08-24 |
| MOH-IL-2020-0040-V240 | Type IA | Completed | 2022-12-07 |
| MOH-IL-2020-0040-V340 | Type IA | Draft | pending |
| MOH-IL-2020-0040-V440 | Type II | In Progress | pending |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.