Roszdravnadzor-2021-0099
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-099
Application Number
Roszdravnadzor-2021-0099
Procedure Type
MAA
Status
Overdue
Linked Product
Market Authorization
Switzerland · Roszdravnadzor
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-099 | CTD | 6.7.1 | 5 | M1 (7), M2 (15), M3 (6), M4 (10), M5 (6) | Completed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2025-05-01 | medium | In Progress |
| Query regarding bioequivalence study design | 2025-04-27 | high | Open |
| Information request: extractables and leachables data | 2025-01-06 | medium | In Progress |
| Information request: extractables and leachables data | 2025-03-15 | medium | Draft |
| Question on comparative dissolution data | 2025-01-30 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-12-05 | medium | Blocked |
| Update SmPC section 4.4 with hepatic impairment data | 2025-06-21 | high | In Progress |
| Provide carcinogenicity study report for 2-year rat study | 2024-12-12 | high | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-295 | SmPC | 8.7 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| Roszdravnadzor-2021-0099-V099 | Major | In Progress | 2024-03-04 |
| Roszdravnadzor-2021-0099-V199 | Type IA | Blocked | 2022-09-04 |
| Roszdravnadzor-2021-0099-V299 | Type IB | Completed | pending |
| Roszdravnadzor-2021-0099-V399 | Type IA | Approved | 2022-11-18 |
| Roszdravnadzor-2021-0099-V499 | Type II | Submitted | 2023-07-31 |
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.