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ANFARM HELLAS S.A. sell "Omeprazole Pd.Sol.Inf 40mg/vial (EU CTD Available)"

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Basic Information

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Sell

Service Name

Omeprazole Pd.Sol.Inf 40mg/vial (EU CTD Available)

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Specifications

  • Indication: Proton-pump inhibitor (PPI) powder for solution for infusion, referencing Losec®/AstraZeneca, for parenteral acid suppression.
  • Dosage Form: Powder for solution for infusion, intended for the labeled route of administration.
  • Strength: 40 mg per vial.
  • Storage Conditions: Store below 25°C in a dry place, protected from direct sunlight, in the original tightly closed packaging.

Other Information

Additional Description:

Referencing Losec®/AstraZeneca, this is a powder for solution for infusion. Omeprazole belongs to the proton-pump inhibitor (PPI) class, which markedly and durably reduces stomach acid production; PPIs' potent acid-suppressing effect supports approval for numerous indications, including short-term management of GERD, erosive esophagitis, H. pylori, and duodenal and gastric ulcers, as well as long-term use for NSAID-associated gastric ulcers, hypersecretory conditions, and maintaining healed erosive esophagitis. An EU CTD dossier is available, with stability studies for Zone II/IVb, a two-year shelf life, batch sizes of 24,000 and 32,500 vials, and packs of 1 or 5 vials.
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ANFARM HELLAS S.A. sell "Omeprazole Pd.Sol.Inf 40mg/vial (EU CTD Available)" | PharmaCountry