Tigecycline 50 mg/Vial Powder for Solution for Infusion (EU CTD Q4: 2020)

Product description

Tigecycline 50 mg/Vial Powder for Solution for Infusion Reference Product: Tygacil® / Pfizer
Description: Tigecycline, a glycylcycline antibiotic, inhibits protein translation in bacteria by binding to the 30S ribosomal subunitand blocking entry of amino-acyl tRNA molecules into the A site of the ribosome. This prevents incorporation ofamino acid residues into elongating peptide chains. In general, Tigecycline is considered bacteriostatic. Tigecycline is indicated in adults and in children from the age of eight years for the treatment of the following infections: Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections and Complicated intra-abdominal infections (cIAI). Tigecycline should be used only in situations where other alternative antibiotics are not suitable.
Dossier Status: On-going / EU CTD ready to file: Q4 2020
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Two (2) years
Batch Sizes: 11,790 vials
Pack Sizes: BT x 10 vials

Specifications

Categories	APIs (Active Pharmaceutical Ingredients)Antibiotics; Finished Dosage FormsInjectables; Contract Services - Contract ServicesLyophilisation
Sales markets	Western Europe; Eastern Europe; Middle East Region (e.g. UAE); Asia; Oceania; North America (USA, Canada); Africa; Central/South America
Supplied from	Greece

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