| Product Information |
|
| Registration Number |
DRP-6564-03
|
| Generic Name |
Irinotecan (as hydrochloride)
|
| Brand Name |
Irebene
|
| Dosage Strength |
20 mg/mL (40 mg/2mL and 100 mg/5 mL)
|
| Dosage Form |
Concentrate for Solution for Infusion (IV)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antineoplastic [Topoisomerase 1 (TOP1) inhibitor]
|
| Packaging |
Amber Tubular USP Type I Glass Vial with bromobutyl rubber stopper, aluminum seal and dark blue flip -off cap x 2 mL and 5 mL / (Box of 1's)
|
| Manufacturer |
Therdose Pharma Pvt. Ltd
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Medethix, Inc
|
| Distributor |
I.E. Medica, Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
04 August 2024
|
| Expiry Date |
18 March 2026
|