Veterinary Medicines

Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses

Authorised
  • Ivermectin
  • Praziquantel
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Product identification

Medicine name:
Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses
Noromectin Praziquantel Duo 18.7 mg/g + 140.3 mg/g перорална паста за коне
Active substance:
  • Ivermectin
  • Praziquantel
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ivermectin
    18.70
    milligram(s)
    /
    1.00
    gram(s)
  • Praziquantel
    140.30
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral paste
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        35
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:
  • An adjustable multidose oral syringe composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings. The oral syringe contains 7.49g of product and is fitted with variable dose capacity. The oral paste is available in the following pack sizes: 1 carton box containing 1 x 7.49g oral syringe
  • An adjustable multidose oral syringe composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings. The oral syringe contains 7.49g of product and is fitted with variable dose capacity. The oral paste is available in the following pack sizes: 1 carton box containing 2 x 7.49g oral syringes
  • An adjustable multidose oral syringe composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings. The oral syringe contains 7.49g of product and is fitted with variable dose capacity. The oral paste is available in the following pack sizes: 1 carton box containing 12 x 7.49g oral syringes
  • An adjustable multidose oral syringe composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings. The oral syringe contains 7.49g of product and is fitted with variable dose capacity. The oral paste is available in the following pack sizes: 1 carton box containing 40 x 7.49g oral syringes
  • An adjustable multidose oral syringe composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings. The oral syringe contains 7.49g of product and is fitted with variable dose capacity. The oral paste is available in the following pack sizes: 1 carton box containing 48 x 7.49g oral syringes
  • An adjustable multidose oral syringe composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings. The oral syringe contains 7.49g of product and is fitted with variable dose capacity. The oral paste is available in the following pack sizes: 1 carton box containing 50 x 7.49g oral syringes

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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • Bulgarian Agency For Food Safety
Authorisation number:
  • 0022-2094
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0311/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Bulgarian (PDF)
Published on: 2/03/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 2/03/2022
Download
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