ANVISA-2020-0025
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-025
Application Number
ANVISA-2020-0025
Procedure Type
MAA
Status
Completed
Linked Product
Market Authorization
Poland · ANVISA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-025 | CTD | 8.9.2 | 5 | M1 (15), M2 (6), M3 (5), M4 (3), M5 (15) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for updated SmPC section 4.1 | 2024-12-26 | low | Draft |
| Query: container closure integrity study methodology | 2025-04-02 | medium | Draft |
| Request for additional clinical data on primary endpoint | 2025-02-07 | high | Draft |
| Information request: manufacturing process change justification | 2025-04-26 | medium | Open |
| Query regarding bioequivalence study design | 2025-04-04 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit harmonised global label per ICH Q12 PLCR | 2025-10-24 | medium | Blocked |
| Provide confirmatory bioequivalence study for 200 mg strength | 2024-11-12 | low | Blocked |
| Submit harmonised global label per ICH Q12 PLCR | 2025-07-20 | low | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-073 | PIL | 14.9 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| ANVISA-2020-0025-V025 | Type IA | In Progress | pending |
| ANVISA-2020-0025-V125 | Type IA | Draft | 2023-12-31 |
| ANVISA-2020-0025-V225 | Type IA | Failed | 2023-06-01 |
| ANVISA-2020-0025-V325 | Minor | Draft | 2023-10-17 |
| ANVISA-2020-0025-V425 | Type II | Overdue | pending |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.