Veterinary Medicines

Omeproshield 370 mg/g oral paste for horses

Authorised
  • Omeprazole
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Product identification

Medicine name:
Omeproshield 370 mg/g oral paste for horses
Omeproshield 370 mg/g Pasta voor oraal gebruik
Omeproshield 370 mg/g Pâte orale
Omeproshield 370 mg/g Paste zum Einnehmen
Active substance:
  • Omeprazole
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Omeprazole
    2.28
    gram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Oral paste
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA02BC01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Immediate packageImmediate packaging: 10 ml syringe containing 6.16 g of paste composed of white polypropylene syringe barrel with a white LDPE cap, a rubber rod tip and a polypropylene plunger rod, with dose divisions calibrated by bodyweight.Outer package and sales presentations- Carton box of 7 syringes
  • Immediate packageImmediate packaging: 10 ml syringe containing 6.16 g of paste composed of white polypropylene syringe barrel with a white LDPE cap, a rubber rod tip and a polypropylene plunger rod, with dose divisions calibrated by bodyweight.Outer package and sales presentations- Carton box of 1 syringe

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent application (Article 13c of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Animal Health Belgium S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France SCS
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V475111
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0488/001
Concerned member states:
  • Austria
  • Belgium
  • Germany
  • Italy
  • Luxembourg
  • Netherlands
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/09/2025
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Dutch (PDF)
Published on: 21/10/2025
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French (PDF)
Published on: 21/10/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 21/10/2025
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French (PDF)
Published on: 21/10/2025
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German (PDF)
Published on: 21/10/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 21/10/2025
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French (PDF)
Published on: 21/10/2025
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German (PDF)
Published on: 21/10/2025
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Combined File of all Documents

English (PDF)
Published on: 2/07/2025
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ie-puar-mr-iev0488001-omeproshield-370-mgg-oral-paste-for-horses-en.pdf

English (PDF)
Published on: 26/08/2024
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