Veterinary Medicines

Peptizole 370 mg/g Oral Paste for Horses

Authorised
  • Omeprazole
Download as PDF

Product identification

Medicine name:
Peptizole 370 mg/g Oral Paste for Horses
Peptizole 370 mg/g belsőleges paszta lovak számára
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:
  • Hungary
Package description:
  • Immediate package Immediate 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 package Immediate 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 package Immediate 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 (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • National Food Chain Safety Office
Authorisation number:
  • 3404/X/13 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0307/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Estonia
  • Finland
  • France
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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."