Esomeprazole Pd.I.S.Inf 40mg/Vial (EU CTD Available)

Product description

Esomeprazole 40 mg/Vial Powder for Solution for Injection/Infusion
Reference Product: Nexium® / Pfizer
Description: Esomeprazole is a proton pump inhibitor indicated for the treatment of the Gastroesophageal Reflux Disease (GERD) with erosive esophagitis (EE) in adults and pediatric patients greater than one month of age, when oral therapy is not possible or appropriate and the Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers following therapeutic endoscopy in adults.
Dossier Status: EU CTD Available
Stability Studies: Zone II / Zone IVb
Shelf life: Two (2) years
Batch Sizes: 40,000 vials
Pack Sizes: BT x 1 vial & x 10 vials

Specifications

Categories	Finished Dosage FormsInjectables; Contract Services - Contract ServicesLyophilisation; Finished Dosage FormsOut-licensing
Sales markets	Middle East Region (e.g. UAE); Oceania; North America (USA, Canada); Africa; Central America (e.g. Mexico); Europe - EU countries; Europe - non EU (e.g. UK, Russia, ex-CIS countries); South America (e.g. Brazil, Colombia)
Supplied from	Greece
Selling Points	International Approvals/Standards

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