TGA / PMDA / NMPA · Asia-Pacific
ferric derisomaltose — TGA / PMDA / NMPA regulatory status
ferric derisomaltose (MONOFER) 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: TGA approved.
Status snapshot
- Status
- TGA approved
- Brand
- MONOFER
- Originator
- A.Menarini Australia Pty Limited
- Mechanism
- Supplement
- Structured fields
- 6
Sponsor / originator context: A.Menarini Australia Pty Limited. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Supplement. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — TGA: approved.
Linked evidence on this spoke: 5 published clinical programs 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 |
|---|---|---|---|---|
| TGA | Australia | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Monofer | Phase 3 | Cosmo Pharmaceuticals | NCT01222884 |
| P-Monofer-CHF-02 | Phase 3 | Anaxis Pharma | 2024-519059-28-00 |
| iron isomaltoside(Monofer®) | Phase 3 | Hospital Authority | NCT03565354 |
| Ferric derisomaltose | Approved | Chinese Academy of | NCT05971732 |
| Ferric derisomaltose | Approved | Chinese Academy of | NCT05991128 |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of ferric derisomaltose?
ferric derisomaltose currently shows TGA 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 ferric derisomaltose 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 ferric derisomaltose?
This spoke lists 5 published programs associated with ferric derisomaltose in our pipeline index.