Veterinary Medicines

GASTROBIM 370 MG/G ORAL PASTE FOR HORSES

Authorised
  • Omeprazole
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Product identification

Medicine name:
GASTROBIM 370 MG/G ORAL PASTE FOR HORSES
Bimeprazol 370 mg/g Pasta doustna
Active substance:
  • Omeprazole
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Omeprazole
    370.00
    milligram(s)
    /
    1.00
    gram(s)
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:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Bimeda Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bimeda Animal Health Limited
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3085
Reference member state:
  • France
Procedure number:
  • FR/V/0405/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Germany
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • Sweden

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
Download
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