| Product Information |
|
| Registration Number |
DR-XY40870
|
| Generic Name |
Cabazitaxel
|
| Brand Name |
Jevtana
|
| Dosage Strength |
60 mg/1.5 mL
|
| Dosage Form |
Concentrate for Solution for Injection (I. V.)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Box 1 containing: Drug Product: 15 mL-Capacity Type I
Clear Glass Vial with Grey Chlorobutyl Rubber Stopper and Aluminum Cap with Light green colored Plastic Flip-Off Seal x 1.5 mL (net content); Ethyl alcohol (as Diluent): 15 mL Type I Clear Glass vial with Grey Chlorobutyl Rubber Stopper and Gold colored aluminum Cap with colorless Plastic Flip-Off Cap x 4.5 mL(net content)
|
| Pharmacologic Category |
Antineoplastic (Taxane)
|
| Manufacturer |
Sanofi-Aventis Deutschland GmbH
|
| Country of Origin |
Germany
|
| Trader |
|
| Importer |
Sanofi Aventis Philippines, Inc.
|
| Distributor |
|
| Application Type |
Initial (from Monitored release)
|
| Issuance Date |
31 May 2022
|
| Expiry Date |
13 January 2027
|