100 mg Paclitaxel formulated as albumin-bound nanoparticles.
Manufacturer
Kexing Biopharm
Country of manufacture
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)
Manufacturing site GMP status
Norwegian Medical Products Agency (Certificate No: 23/28995-19)
US FDA establishment registration (FEI; registration is not an FDA approval)
3008467694
API manufacturing site GMP status
US FDA GMP, COFEPRIS (Mexico) GMP and EDQM (Europe) Certified
Additional GMP certification
Also certified by COFEPRIS (Mexico) and EDQM (Europe)
Therapeutic Area
Oncology
Country of manufacture
Europaxel is identical to the product authorized in the European Union under the brand name Apexelsin. EMA product number: EMEA/H/C/005997
Manufacturing site country
China
Additional Information
No items found.
Prescription-only medicine. This information is intended for healthcare professionals and prospective business partners. It is not promotional material and is not intended for patients. For approved product information, consult the Georgian medicines register or contact us. To report a suspected side effect from a medicine supplied by Mermisi, please contact us.
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