HC-2024-0066
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-066
Application Number
HC-2024-0066
Procedure Type
sBLA
Status
Submitted
Linked Product
Market Authorization
Canada · HC
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-066 | eCTD | 1.5.8 | 5 | M1 (8), M2 (9), M3 (5), M4 (11), M5 (5) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: manufacturing process change justification | 2025-01-21 | medium | In Progress |
| Request for post-marketing commitment progress update | 2025-01-10 | medium | Open |
| Deficiency: inadequate paediatric data justification | 2025-03-03 | low | Overdue |
| Request for updated SmPC section 4.1 | 2024-12-15 | low | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-05-24 | high | Open |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-10-11 | high | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-196 | IFU | 15.4 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| HC-2024-0066-V066 | Type IB | Active | 2022-12-31 |
| HC-2024-0066-V166 | Type IA | Failed | pending |
| HC-2024-0066-V266 | Minor | Overdue | pending |
| HC-2024-0066-V366 | Type II | Pending | 2024-02-25 |
| HC-2024-0066-V466 | Type IA | Approved | 2023-05-15 |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 0, failed/blocked sequences: 2, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.