COFEPRIS-2021-0074
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-074
Application Number
COFEPRIS-2021-0074
Procedure Type
sBLA
Status
Draft
Linked Product
Market Authorization
Netherlands · COFEPRIS
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-074 | eCTD | 4.2.2 | 5 | M1 (7), M2 (11), M3 (10), M4 (14), M5 (6) | Draft |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for benefit-risk assessment addendum | 2025-03-12 | high | Overdue |
| Request for additional clinical data on primary endpoint | 2025-02-27 | medium | Draft |
| Request for benefit-risk assessment addendum | 2024-12-13 | low | Open |
| Request for updated SmPC section 4.1 | 2025-02-07 | low | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide carcinogenicity study report for 2-year rat study | 2025-08-23 | low | In Progress |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-07-06 | medium | Open |
| Provide carcinogenicity study report for 2-year rat study | 2025-08-25 | low | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-220 | Labeling | 6.5 | Approved |
| LBL-221 | SmPC | 19.2 | Pending |
| LBL-222 | PIL | 14.5 | Submitted |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| COFEPRIS-2021-0074-V074 | Type IA | In Progress | 2022-12-01 |
| COFEPRIS-2021-0074-V174 | Major | Active | 2023-12-08 |
| COFEPRIS-2021-0074-V274 | Type IB | Blocked | pending |
| COFEPRIS-2021-0074-V374 | Type IB | Blocked | pending |
| COFEPRIS-2021-0074-V474 | Minor | Failed | pending |
Inspection Readiness Risk Panel
Risk Score: 1 · Overdue commitments: 0, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.