Product Details

Docetaxel 10 mg/mL Concentrate for Solution for Infusion

Docetaxel (Docetaxel Trihydrate)
10 mg/mL
Concentrate for solution for infusion

ROA

Intravenous

Applicant Name

Novartis Nigeria Limited

NRN

B4-7683

Status

Active


Composition

Docetaxel 10 mg/mL Concentrate for Solution for Infusion. Each mL of concentrate contains: Docetaxel 10 mg Each vial of 2 mL contains 20 mg docetaxel anhydrous (10 mg/mL). Each vial of 8 mL contains 80 mg docetaxel anhydrous (10 mg/mL) Excipient with known effect (per mL): Each ml of concentrate for solution for infusion contains 265 mg of ethanol which is equivalent to 26% w/w  

ATC Code/ATCvet Code

L01CD02  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1 x 2 mL; 1 x 8 mL (in vials)  

Product Description

Concentrate for Solution for Infusion Clear, colorless to pale, yellow solution; pH 3.0 – 4.5, free from visible particles

Manufacturer Name

Fareva Unterach GmbH

Manufacturer Country

AUSTRIA  

Approval Date

2023-05-25  

Expiry Date

2028-05-24