TGA / PMDA / NMPA · Asia-Pacific
nonacog beta pegol — TGA / PMDA / NMPA regulatory status
nonacog beta pegol (REFIXIA) regulatory status in the Asia-Pacific is tracked from public TGA / PMDA / NMPA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: PMDA approved.
Status snapshot
- Status
- PMDA approved
- Brand
- REFIXIA
- Mechanism
- Coagulation factor IX exogenous protein
- Target
- Coagulation factor IX
- Structured fields
- 6
Pharmacology context used for competitive intelligence: Coagulation factor IX exogenous protein. Target: Coagulation factor IX. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — PMDA: approved.
Linked evidence on this spoke: 1 published clinical program and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| PMDA | Japan | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| nonacog beta pegol | Phase 3 | Novo Nordisk A/S | NCT02141074 |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of nonacog beta pegol?
nonacog beta pegol currently shows PMDA approved in our Asia-Pacific regulatory index. Confirm on the official TGA / PMDA / NMPA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get nonacog beta pegol regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to nonacog beta pegol?
This spoke lists 1 published program associated with nonacog beta pegol in our pipeline index.