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Noroclav Intramammary Suspension for Lactating Cows

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
  • Prednisolone
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Product identification

Medicine name:
Noroclav Intramammary Suspension for Lactating Cows
Active substance:
  • Amoxicillin trihydrate
  • Potassium clavulanate
  • Prednisolone
Target species:
  • Cattle (lactating cow)
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    229.60
    milligram(s)
    /
    1.00
    Applicator
  • Potassium clavulanate
    59.60
    milligram(s)
    /
    1.00
    Applicator
  • Prednisolone
    10.00
    milligram(s)
    /
    1.00
    Applicator
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle (lactating cow)
      • Meat and offal
        7
        day
      • Milk
        84
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ51RV01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • (ID1) 9 gram(s): Box (cardboard) with 3 Applicator (low-density polyethylene) each with 3 gram(s)
  • (ID2) 36 gram(s): Box (cardboard) with 12 Applicator (low-density polyethylene) each with 3 gram(s)
  • (ID3) 72 gram(s): Box (cardboard) with 24 Applicator (low-density polyethylene) each with 3 gram(s)
  • (ID4) 360 gram(s): Bucket with 120 Applicator (low-density polyethylene) each with 3 gram(s)

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 (Ireland) Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402467.00.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0328/001
Concerned member states:
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 20/03/2026
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German (PDF)
Published on: 20/03/2026
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2402467-paren-20190329.rtf

English (RTF)
Published on: 18/12/2024
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