Veterinary Medicines

Synulox Lactating Cow Intramammary suspension.

Authorised
  • Prednisolone
  • Amoxicillin trihydrate
  • Potassium clavulanate
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Product identification

Medicine name:
Synulox Lactating Cow Intramammary suspension.
Synulox comp. vet. intramammarier, suspensjon, til lakterende storfe
Active substance:
  • Prednisolone
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Cattle
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Prednisolone
    10.00
    milligram(s)
    /
    1.00
    Syringe
  • Amoxicillin trihydrate
    200.00
    milligram(s)
    /
    1.00
    Syringe
  • Potassium clavulanate
    59.56
    milligram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle
      • Milk
        60
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ51RV01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:
  • Low density polyethylene syringes packed in cartons containing 12 syringes.
  • Low density polyethylene syringes packed in cartons containing 24 syringes.
  • Low density polyethylene syringes packed in cartons containing 300 syringes.
  • Low density polyethylene syringes packed in cartons containing 3 syringes.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Animal Health ApS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Haupt Pharma Latina S.r.l.
Responsible authority:
  • Norwegian Medicines Agency
Authorisation number:
  • 94-638
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0605/001
Concerned member states:
  • Austria
  • Bulgaria
  • Cyprus
  • Czechia
  • France
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
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Norwegian (PDF)
Published on: 6/06/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 6/06/2023
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