Veterinary Medicines

GastroGard 370 mg/g oral paste

Authorised
  • Omeprazole
Download as PDF

Product identification

Medicine name:
GastroGard 370 mg/g oral paste
GastroGard 370 mg/g - Paste zum Eingeben für Pferde
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:
  • Austria
Package description:
  • Available only in German
  • Immediate packaging: 10 ml syringe containing 6.16 g of paste composed of white polypropylene syringes barrel with a white LDPE cap, a rubber rod tip and a polypropylene plunger rod, with dose divisions calibrated by body weight.Outer packaging and sales presentations-Carton box of 14 syringes
  • Immediate packaging: 10 ml syringe containing 6.16 g of paste composed of white polypropylene syringes barrel with a white LDPE cap, a rubber rod tip and a polypropylene plunger rod, with dose divisions calibrated by body weight.Outer packaging and sales presentations-Carton box of 14 syringes
  • Immediate packaging: 10 ml syringe containing 6.16 g of paste composed of white polypropylene syringes barrel with a white LDPE cap, a rubber rod tip and a polypropylene plunger rod, with dose divisions calibrated by body weight.Outer packaging and sales presentations-Carton box of 14 syringes

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Animal Health France
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France SCS
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-00608
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0489/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 30/03/2025
Download
German (PDF)
Published on: 20/06/2024
Updated on: 6/02/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 20/06/2024
Updated on: 6/02/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 20/06/2024
Updated on: 6/02/2025
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."