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)
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The drug is intended for the treatment of postmenopausal women with locally advanced or metastatic breast cancer that has estrogen receptor-positive tumors. It is used both as monotherapy and in combination with palbociclib.
Dosage form: solution for injection
Active substance Dosage fulvestrant 250 mg/5 ml ATC: L02BA03