Active Ingredient (INN)
100 mg Paclitaxel formulated as albumin-bound nanoparticles.
Manufacturer
Kexing Biopharm
Country
China
Form/Dose
Lyophilized powder for dispersion for infusion (Intravenous Use).
Concentration
After reconstitution, each mL contains 5 mg paclitaxel
Excipients
Human serum albumin (contains sodium caprylate and N-acetyl-L-tryptophan)
EU GMP Cerified
Norwegian Medical Products Agency (Certificate No: 23/28995-19)
US FDA Registered
Establishment Identifier 3008467694.
HIGH-QUALITY API
US FDA GMP, COFEPRIS (Mexico) GMP and EDQM (Europe) Certified
Global compliance
Also certified by COFEPRIS (Mexico) and EDQM (Europe)
Therapeutic Area
Oncology
Country of Authorization
Europaxel is identical to the product authorized in the European Union under the brand name Apexelsin. EMA product number: EMEA/H/C/005997
Country of Manufacturing
China
Additonal Information
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