| Product Information |
|
| Registration Number |
DRP-13145
|
| Generic Name |
Irinotecan (as hydrochloride)
|
| Brand Name |
Irnizet 40
|
| Dosage Strength |
20 mg/mL (40 mg/ 2 mL)
|
| Dosage Form |
Concentrate Solution for I.V.
Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic
|
| Packaging |
Type I Tubular Amber Glass Vial with Bromo Butyl
stopper and Aluminium seal with Polypropylene Disc x 2 mL (Box of 1's)
|
| Manufacturer |
Eugia Pharma Specialties Limited
|
| Country of Origin |
India
|
| Trader |
Aurobindo Pharma Pvt. Ltd.
|
| Importer |
MedEthix, Inc.
|
| Distributor |
MedEthix, Inc.
|
| Application Type |
Initial (Correction)
|
| Issuance Date |
10 July 2024
|
| Expiry Date |
07 December 2027
|