MOH-IL-2020-0100
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-100
Application Number
MOH-IL-2020-0100
Procedure Type
Label Update
Status
Completed
Linked Product
Market Authorization
Germany · MOH-IL
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-100 | eCTD | 4.3.9 | 5 | M1 (7), M2 (9), M3 (8), M4 (9), M5 (12) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for post-marketing commitment progress update | 2025-04-22 | medium | In Progress |
| Request for updated SmPC section 4.1 | 2025-02-13 | medium | Overdue |
| Request for post-marketing commitment progress update | 2024-12-15 | low | Draft |
| Information request: extractables and leachables data | 2024-12-19 | low | Open |
| GMP inspection findings clarification | 2025-03-27 | low | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-12-14 | high | In Progress |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-10-21 | high | Open |
| Submit final study report for paediatric use study KCL-PED-001 | 2024-12-19 | medium | In Progress |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MOH-IL-2020-0100-V100 | Type IA | Blocked | 2023-01-26 |
| MOH-IL-2020-0100-V200 | Major | Pending | 2024-04-12 |
| MOH-IL-2020-0100-V300 | Type II | Submitted | 2023-06-24 |
| MOH-IL-2020-0100-V400 | Type II | Submitted | 2023-10-13 |
| MOH-IL-2020-0100-V500 | Minor | Failed | 2022-12-18 |
Inspection Readiness Risk Panel
Risk Score: 0 · Overdue commitments: 0, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.