Roszdravnadzor-2021-0039
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-039
Application Number
Roszdravnadzor-2021-0039
Procedure Type
Type IB Variation
Status
Draft
Linked Product
Market Authorization
Switzerland · Roszdravnadzor
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-039 | NeeS | 6.9.6 | 5 | M1 (14), M2 (6), M3 (7), M4 (9), M5 (14) | Draft |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for post-marketing commitment progress update | 2024-12-08 | low | In Progress |
| Deficiency: inadequate paediatric data justification | 2025-01-20 | medium | In Progress |
| Request for updated SmPC section 4.1 | 2025-02-17 | low | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Complete Phase IV post-marketing observational study (n=500) | 2025-08-14 | medium | In Progress |
| Update SmPC section 4.4 with hepatic impairment data | 2025-09-18 | medium | Open |
| Submit final study report for paediatric use study KCL-PED-001 | 2024-12-27 | low | Blocked |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| Roszdravnadzor-2021-0039-V039 | Type IB | Blocked | pending |
| Roszdravnadzor-2021-0039-V139 | Major | Draft | 2022-08-29 |
| Roszdravnadzor-2021-0039-V239 | Type IB | Failed | pending |
| Roszdravnadzor-2021-0039-V339 | Major | Approved | 2022-08-04 |
| Roszdravnadzor-2021-0039-V439 | Major | Overdue | 2022-12-18 |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 0, failed/blocked sequences: 2, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.