Veterinary Medicines

GastroGard 370 mg/g oral paste

Authorised
  • Omeprazole
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Product identification

Medicine name:
GastroGard 370 mg/g oral paste
Gastrogard 370 mg/g oral pasta
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:
  • Denmark
Available in:
  • Denmark
Package description:
  • 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 1 syringe
  • 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-Bulk pack of 72 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 7 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 Denmark A/S
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 35512
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
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Danish (PDF)
Published on: 14/10/2024
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