Roszdravnadzor-2021-0079
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-079
Application Number
Roszdravnadzor-2021-0079
Procedure Type
Lifecycle Extension
Status
Failed
Linked Product
Market Authorization
Mexico · Roszdravnadzor
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-079 | NeeS | 5.8.8 | 5 | M1 (3), M2 (4), M3 (14), M4 (5), M5 (14) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: extractables and leachables data | 2025-01-05 | medium | Overdue |
| Information request: extractables and leachables data | 2025-03-04 | medium | Overdue |
| Query regarding bioequivalence study design | 2025-03-01 | high | Open |
| Deficiency letter: missing stability data for 40°C condition | 2024-12-05 | medium | Draft |
| Query: container closure integrity study methodology | 2025-03-05 | low | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-09-15 | medium | Open |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-08-25 | high | In Progress |
| Update SmPC section 4.4 with hepatic impairment data | 2025-06-26 | high | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-235 | IFU | 8.1 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| Roszdravnadzor-2021-0079-V079 | Type II | Draft | pending |
| Roszdravnadzor-2021-0079-V179 | Type IB | Draft | 2023-08-16 |
| Roszdravnadzor-2021-0079-V279 | Type IA | Blocked | pending |
| Roszdravnadzor-2021-0079-V379 | Type II | Blocked | 2024-03-11 |
| Roszdravnadzor-2021-0079-V479 | Major | In Progress | 2023-07-11 |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 0, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.