Active substance
Ferric derisomaltose
- SFDA 1
- US FDA 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Monofer | 100 mg/ml | Solution for injection/concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 403.60 | NCE · Prescription | PHARMACOSMOS A/S | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MONOFERRIC | 1GM/10ML (100MG/ML) | solution · intravenous | PHARMACOSMOS | Prescription | 16 Jan 2020 |
| MONOFERRIC | 100MG/ML (100MG/ML); 500MG/5ML (100MG/ML) | solution · intravenous | PHARMACOSMOS | Discontinued | 16 Jan 2020 |
Safety signals and safety-related labeling changes
- US FDA 1 Aug 2024 MONOFERRIC — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.