Veterinary Medicines

Peptaleve 370 mg/g Oral Paste for Horses

Authorised
  • Omeprazole
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Product identification

Medicine name:
Peptaleve 370 mg/g Oral Paste for Horses
Peptaleve 370 mg/g Oral Paste for Horses
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:
  • United Kingdom (Northern Ireland)
Package description:
  • Immediate packageImmediate packaging: 7 ml oral syringe containing 7.57 g of paste composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings.Outer package and sales presentations- Bucket of 72 oral syringes.
  • Immediate packageImmediate packaging: 7 ml oral syringe containing 7.57 g of paste composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings.Outer package and sales presentations- Carton box of 7 oral syringes
  • Immediate packageImmediate packaging: 7 ml oral syringe containing 7.57 g of paste composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings.Outer package and sales presentations- Carton box of 1 oral syringe

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:
  • Norbrook Laboratories Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Ltd
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • Vm 02000/4443
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0655/001
Concerned member states:
  • Netherlands
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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Combined File of all Documents

English (PDF)
Published on: 13/04/2025
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