| Product Information |
|
| Registration Number |
DRP-12775
|
| Generic Name |
Irinotecan Hydrochloride
|
| Brand Name |
Irnizet 100
|
| Dosage Strength |
20 mg/ mL (100 mg/ 5 mL)
|
| Dosage Form |
Concentrate Solution for Injection for I.V. Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic (Topoisomerase 1 (TOP1) Inhibitor)
|
| Packaging |
Type I tubular amber glass vial with gray bromobutyl
rubber stopper and aluminum seal with polypropylene disc x 5 mL (Box of 1's)
|
| Manufacturer |
Eugia Pharma Specialities Limited
|
| Country of Origin |
India
|
| Trader |
Aurobindo Pharma Limited
|
| Importer |
Medethix, Inc.
|
| Distributor |
Medethix, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
06 October 2022
|
| Expiry Date |
06 October 2027
|