TITCK-2024-0036
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-036
Application Number
TITCK-2024-0036
Procedure Type
Type IB Variation
Status
Active
Linked Product
Market Authorization
Canada · TITCK
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-036 | CTD | 5.0.3 | 5 | M1 (7), M2 (9), M3 (14), M4 (7), M5 (15) | Blocked |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency: inadequate paediatric data justification | 2025-03-12 | medium | Overdue |
| Information request: extractables and leachables data | 2025-02-05 | medium | Draft |
| Question on comparative dissolution data | 2025-01-16 | medium | Open |
| Request for post-marketing commitment progress update | 2025-03-29 | medium | Overdue |
| Request for additional clinical data on primary endpoint | 2025-03-30 | medium | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2024-10-20 | high | In Progress |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2024-12-27 | low | Overdue |
| Update SmPC section 4.4 with hepatic impairment data | 2025-01-15 | low | Overdue |
| Update SmPC section 4.4 with hepatic impairment data | 2025-03-18 | medium | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-106 | Labeling | 3.5 | Approved |
| LBL-107 | SmPC | 13.5 | Pending |
| LBL-108 | IFU | 12.5 | Submitted |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| TITCK-2024-0036-V036 | Type IA | In Progress | 2022-12-20 |
| TITCK-2024-0036-V136 | Type IA | Completed | 2024-05-09 |
| TITCK-2024-0036-V236 | Major | Failed | 2022-11-21 |
| TITCK-2024-0036-V336 | Type IB | Approved | 2023-05-30 |
| TITCK-2024-0036-V436 | Type II | In Progress | pending |
Inspection Readiness Risk Panel
Risk Score: 6 · Overdue commitments: 2, failed/blocked sequences: 1, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.