SwissMedic-2021-0089
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-089
Application Number
SwissMedic-2021-0089
Procedure Type
Type II Variation
Status
Completed
Linked Product
Market Authorization
Portugal · SwissMedic
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-089 | NeeS | 8.8.8 | 5 | M1 (4), M2 (9), M3 (9), M4 (10), M5 (5) | Approved |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for benefit-risk assessment addendum | 2025-02-23 | medium | Draft |
| Request for post-marketing commitment progress update | 2025-04-09 | high | Open |
| Deficiency: inadequate paediatric data justification | 2025-01-31 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide carcinogenicity study report for 2-year rat study | 2025-01-25 | high | In Progress |
| Validate analytical method for dissolution test per USP <711> | 2025-07-23 | high | Open |
| Provide carcinogenicity study report for 2-year rat study | 2025-06-29 | high | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-265 | PIL | 8.1 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SwissMedic-2021-0089-V089 | Type II | Blocked | 2023-04-16 |
| SwissMedic-2021-0089-V189 | Type II | Blocked | pending |
| SwissMedic-2021-0089-V289 | Minor | Approved | 2023-04-16 |
| SwissMedic-2021-0089-V389 | Type IB | Active | 2024-04-12 |
| SwissMedic-2021-0089-V489 | Type IA | Blocked | 2024-03-02 |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 0, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.