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:
NOROMECTIN PRAZIQUANTEL DUO, 18,7 mg/g + 140,3 mg/g pastă orală pentru cai
Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses
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:
  • Romania
Available in:
  • Romania
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 andend cap, with polypropylene dosing rings. The oral syringe contains 7.49g of productand 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 andend cap, with polypropylene dosing rings. The oral syringe contains 7.49g of productand 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:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 190110
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: 2/03/2025
Download

Combined File of all Documents

English (PDF)
Published on: 2/03/2025
Download
Romanian (PDF)
Published on: 16/04/2025
Download
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