MOH-IL-2020-0060
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-060
Application Number
MOH-IL-2020-0060
Procedure Type
Lifecycle Extension
Status
Failed
Linked Product
Market Authorization
Denmark · MOH-IL
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-060 | eCTD | 5.4.3 | 5 | M1 (6), M2 (11), M3 (10), M4 (10), M5 (15) | Active |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency letter: missing stability data for 40°C condition | 2025-02-04 | high | Open |
| Query: container closure integrity study methodology | 2025-02-06 | medium | Overdue |
| Query: container closure integrity study methodology | 2025-01-27 | low | Open |
| Deficiency letter: missing stability data for 40°C condition | 2025-02-27 | medium | Draft |
| Information request: manufacturing process change justification | 2025-03-02 | low | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Update SmPC section 4.4 with hepatic impairment data | 2025-07-09 | high | Blocked |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-03-04 | medium | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-178 | Labeling | 17.8 | Approved |
| LBL-179 | IFU | 6.0 | Approved |
| LBL-180 | PIL | 16.7 | Active |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MOH-IL-2020-0060-V060 | Minor | Overdue | 2022-10-06 |
| MOH-IL-2020-0060-V160 | Type II | Draft | pending |
| MOH-IL-2020-0060-V260 | Minor | Submitted | 2022-11-24 |
| MOH-IL-2020-0060-V360 | Type II | Active | 2024-03-06 |
| MOH-IL-2020-0060-V460 | Minor | Blocked | 2023-01-03 |
Inspection Readiness Risk Panel
Risk Score: 1 · Overdue commitments: 0, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.