Deferiprone Capsule Technical Specification:
| Product Name: | Deferiprone Capsule 500mg |
| Brand Name: | Generic |
| Strength: | 250mg, 500mg |
| Dosage Form: | Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 50s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP,DMF,FSC, COPP and CTD Dossier |
| Therapeutic use: | Iron-chelator/ Anti-thalassemia |
| Indication: | Deferiprone is used to remove excess iron in the body in adults and children 3 years of age and older who have thalassemia (an inherited condition that causes a low number of red blood cells). |
| Storage: | Store below 30℃, protect from Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Deferiprone Capsule 250mg
Deferiprone Capsule 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Hard gelatin capsule contains:
Deferiprone USP …….500mg
Excipients……q.s.
Color: Approved color used in capsule empty shell
THERAPEUTIC INDICATIONS:
Deferiprone is used to remove excess iron in the body in adults and children 3 years of age and older who have thalassemia (an inherited condition that causes a low number of red blood cells).
CAUTION & WARNING:
Keep out of reach of children.
WARNING: To be sold against the prescription of Hematologists only.