ANVISA-2020-0065
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-065
Application Number
ANVISA-2020-0065
Procedure Type
sNDA
Status
Completed
Linked Product
Market Authorization
Brazil · ANVISA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-065 | CTD | 1.7.3 | 5 | M1 (9), M2 (15), M3 (13), M4 (7), M5 (9) | Completed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for additional clinical data on primary endpoint | 2024-12-24 | low | Open |
| GMP inspection findings clarification | 2025-04-29 | medium | In Progress |
| Question on comparative dissolution data | 2025-04-04 | medium | Overdue |
| Request for benefit-risk assessment addendum | 2025-04-02 | medium | Overdue |
| GMP inspection findings clarification | 2025-02-16 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-01-21 | medium | Overdue |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-07-29 | medium | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-193 | SmPC | 20.6 | Approved |
| LBL-194 | Labeling | 3.2 | In Progress |
| LBL-195 | Labeling | 8.8 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| ANVISA-2020-0065-V065 | Major | Blocked | 2023-04-22 |
| ANVISA-2020-0065-V165 | Major | Approved | pending |
| ANVISA-2020-0065-V265 | Type IB | Draft | 2022-12-07 |
| ANVISA-2020-0065-V365 | Type IA | In Progress | pending |
| ANVISA-2020-0065-V465 | Minor | Failed | 2024-05-19 |
Inspection Readiness Risk Panel
Risk Score: 2 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.