Omeprazole Ps.Inj.Sol 40mg/vial (EU CTD Available)

Product description

Omeprazole 40mg/vial Powder for Solution for Injection  Reference Product: Losec® / Astra Zeneca
Description: Omeprazole belongs to the ATC category of Proton-pump inhibitors which is a group of drugs whose main action is a pronounced and long-lasting reduction of stomach acid production.Due to their effective acid-suppressing effects, PPIs are approved for numerous indications, including short-term management of gastroesophageal reflux disease, erosive esophagitis, H pylori, and duodenal and gastric ulcers. Long-term indications for PPIs include nonsteroidal anti-inflammatory drug–associated gastric ulcers, hypersecretory conditions, and maintenance of healing erosive esophagitis.
Dossier Status EU CTD Available
Stability Studies Zone II / Zone IVb 
Shelf life: Three (3) years 
Batch Size: 24,000 & 32,500 vials +25,000 amps of 10ml solvent 
Pack Size: BT x 1 vial + 1 amp x 10ml solvent
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Categories Pharmaceutical Products / ATC coding | Alimentary Tract and MetabolismDrugs for Functional Gastrointestinal Disorders; Finished Dosage FormsInjectables; Contract Services - Contract ServicesLyophilisation
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); South East Asia (e.g. Thailand, Philippines, Singapore)
Supplied from Greece
Selling Points International Approvals/Standards

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