Veterinary Medicines

Synuclav Suspension for Injection

Authorised
  • Potassium clavulanate
  • Amoxicillin trihydrate
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Product identification

Medicine name:
Synuclav Suspension for Injection
Combisyn 14,0/3,5 % w/v Stungulyf, dreifa handa nautgripum og hundum
Active substance:
  • Potassium clavulanate
  • Amoxicillin trihydrate
Target species:
  • Cattle
  • Dog
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Potassium clavulanate
    35.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Amoxicillin trihydrate
    140.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        42
        day
    • Cattle
      • Milk
        60
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Iceland
Available in:
  • Iceland
Package description:
  • box containing 1 vial of 100 ml
  • box containing 1 vial of 50 ml

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 Laboratories (Ireland) Limited
Responsible authority:
  • Icelandic Medicines Agency
Authorisation number:
  • IS/2/11/006/01
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0354/001
Concerned member states:
  • Belgium
  • France
  • Iceland
  • Italy
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 23/03/2023
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Icelandic (PDF)
Published on: 21/07/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Icelandic (PDF)
Published on: 21/07/2022
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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