TITCK-2024-0056
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-056
Application Number
TITCK-2024-0056
Procedure Type
Label Update
Status
Approved
Linked Product
Market Authorization
Sweden · TITCK
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-056 | CTD | 6.8.6 | 5 | M1 (15), M2 (11), M3 (8), M4 (14), M5 (12) | Completed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: extractables and leachables data | 2025-01-05 | medium | Draft |
| Information request: extractables and leachables data | 2025-01-29 | high | Overdue |
| Information request: manufacturing process change justification | 2025-02-12 | high | Open |
| Information request: manufacturing process change justification | 2025-01-14 | high | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-10-27 | high | In Progress |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-12-15 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-166 | PIL | 1.1 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TITCK-2024-0056-V056 | Minor | Submitted | 2022-12-11 |
| TITCK-2024-0056-V156 | Type IB | Overdue | pending |
| TITCK-2024-0056-V256 | Type IA | Overdue | 2022-11-29 |
| TITCK-2024-0056-V356 | Type IB | Submitted | 2023-08-15 |
| TITCK-2024-0056-V456 | Type II | Failed | 2023-09-01 |
Inspection Readiness Risk Panel
Risk Score: 7 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 3.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.