Veterinary Medicines

Equizol 400 mg gastro-resistant granules for horses

Authorised
  • Omeprazole
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Product identification

Medicine name:
Equizol 400 mg gastro-resistant granules for horses
Hippozol vet. 400 mg enterogranulat til hest
Active substance:
  • Omeprazole
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Omeprazole
    80.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Gastro-resistant granules
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        2
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA02BC01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Available in:
  • Norway
Package description:
  • (ID7) 1000 gram(s): unspecified outer container with 200 Bag (PolyEthylene; Aluminium; Paper) each with 5 gram(s)
  • (ID6) 560 gram(s): unspecified outer container with 112 Bag (PolyEthylene; Aluminium; Paper) each with 5 gram(s)
  • (ID5) 500 gram(s): unspecified outer container with 100 Bag (PolyEthylene; Aluminium; Paper) each with 5 gram(s)
  • (ID4) 420 gram(s): unspecified outer container with 84 Bag (PolyEthylene; Aluminium; Paper) each with 5 gram(s)
  • (ID3) 280 gram(s): unspecified outer container with 56 Bag (PolyEthylene; Aluminium; Paper) each with 5 gram(s)
  • (ID2) 140 gram(s): unspecified outer container with 28 Bag (PolyEthylene; Aluminium; Paper) each with 5 gram(s)
  • (ID1) 70 gram(s): unspecified outer container with 14 Bag (PolyEthylene; Aluminium; Paper) each with 5 gram(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 16-11276
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0318/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 15/02/2022
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Norwegian (PDF)
Published on: 28/01/2022
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