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 orale per cavalli
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:
  • Italy
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

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 Italia S.p.A. In Breve Boehringer Ingelheim Ah It S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France SCS
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104738
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 5/02/2024
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Summary of Product Characteristics

English (PDF)
Published on: 26/08/2024
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ie-puar-mr-iev0488001-omeproshield-370-mgg-oral-paste-for-horses-en.pdf

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