Roszdravnadzor-2021-0059
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-059
Application Number
Roszdravnadzor-2021-0059
Procedure Type
BLA
Status
Submitted
Linked Product
Market Authorization
Portugal · Roszdravnadzor
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-059 | NeeS | 1.3.9 | 5 | M1 (9), M2 (9), M3 (4), M4 (9), M5 (11) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query: container closure integrity study methodology | 2025-03-03 | medium | Draft |
| Deficiency letter: missing stability data for 40°C condition | 2025-02-08 | high | In Progress |
| Deficiency: inadequate paediatric data justification | 2025-04-20 | medium | Overdue |
| Information request: extractables and leachables data | 2025-02-25 | low | Overdue |
| Deficiency: inadequate paediatric data justification | 2025-04-12 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-07-02 | low | Overdue |
| Submit harmonised global label per ICH Q12 PLCR | 2025-09-22 | high | Open |
| Provide confirmatory bioequivalence study for 200 mg strength | 2024-11-18 | medium | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-175 | Labeling | 11.6 | Submitted |
| LBL-176 | SmPC | 18.7 | Approved |
| LBL-177 | Labeling | 19.1 | Submitted |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| Roszdravnadzor-2021-0059-V059 | Type II | Draft | 2022-08-24 |
| Roszdravnadzor-2021-0059-V159 | Type IB | Draft | 2023-12-16 |
| Roszdravnadzor-2021-0059-V259 | Type IA | Failed | 2022-08-21 |
| Roszdravnadzor-2021-0059-V359 | Type IA | Completed | 2023-08-21 |
| Roszdravnadzor-2021-0059-V459 | Type II | Approved | 2024-01-30 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.