L02BA03

Ukraine

Fulvestrant

Falvax

Form: solution for injection

Active substance	Dosage
fulvestrant	250 mg/5 ml

ATC code: L02BA03

Manufacturer: Dr. Reddy's Laboratories Limited, Manufacturing Unit - 9

Faslodex

Form: solution for injection

Active substance	Dosage
fulvestrant	250 mg/5 ml

ATC code: L02BA03

Manufacturer: Wetter Pharma-Fertigungs GmbH & Co. KG (manufacturing, primary packaging, visual inspection, batch testing; description, identification by infrared (IR) spectroscopy, quantitative determination of fulvestrant by high-performance liquid chromatography (HPLC), degradation products by HPLC, volume of injectable solution in containers, functional testing of PFS, bacterial endotoxins, mechanical particulates (sub-visible particles), sterility, ethanol content by gas chromatography (GC), benzyl alcohol content by GC, benzyl benzoate content by GC; visual inspection; visual inspection, batch testing (sterility testing); manufacturing, primary packaging, visual inspection, batch testing; description, identification by infrared (IR) spectroscopy, quantitative determination of fulvestrant by high-performance liquid chromatography (HPLC), degradation products by HPLC, volume of injectable solution in containers, functional testing of PFS, bacterial endotoxins, mechanical particulates (sub-visible particles), sterility, ethanol content by gas chromatography (GC), benzyl alcohol content by GC, benzyl benzoate content by GC)

Fulvadject

Form: solution for injection

Active substance	Dosage
fulvestrant	250 mg/5 ml

ATC code: L02BA03

Manufacturer: K.T. ROMFARM COMPANY S.R.L. (manufacturing and primary packaging of medicinal product; physico-chemical control and batch release; secondary packaging and biological and microbiological control of medicinal product)

Fulvestrant ever pharma

Form: solution for injection

Active substance	Dosage
fulvestrant	250 mg/5 ml

ATC code: L02BA03

Manufacturer: EVER Pharma Jena GmbH (manufacturing of medicinal product, responsible for batch control and batch release; alternative unit for secondary packaging)

Fulvestrant-vista

Form: solution for injection

Active substance	Dosage
fulvestrant	250 mg/5 ml

ATC code: L02BA03

Manufacturer: Laboratorios Echevarne, S.A. (manufacturer responsible for control of sterile products)