SwissMedic-2021-0069
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-069
Application Number
SwissMedic-2021-0069
Procedure Type
BLA
Status
Active
Linked Product
Market Authorization
Switzerland · SwissMedic
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-069 | CTD | 2.9.6 | 5 | M1 (4), M2 (7), M3 (12), M4 (14), M5 (10) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for updated SmPC section 4.1 | 2024-12-06 | low | Overdue |
| Request for post-marketing commitment progress update | 2025-03-26 | low | Open |
| Deficiency: inadequate paediatric data justification | 2025-01-02 | high | In Progress |
| GMP inspection findings clarification | 2024-11-27 | low | Open |
| Information request: extractables and leachables data | 2024-12-17 | medium | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-03-24 | low | In Progress |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SwissMedic-2021-0069-V069 | Major | Submitted | 2023-08-14 |
| SwissMedic-2021-0069-V169 | Type IA | Overdue | 2024-02-04 |
| SwissMedic-2021-0069-V269 | Major | Approved | pending |
| SwissMedic-2021-0069-V369 | Type II | Submitted | pending |
| SwissMedic-2021-0069-V469 | Minor | In Progress | 2023-01-16 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 0, failed/blocked sequences: 2, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.