Veterinary Medicines

Combiclav Intramammary Suspension for Lactating Cows

Authorised
  • Prednisolone
  • Potassium clavulanate
  • Amoxicillin trihydrate
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Product identification

Medicine name:
Combiclav Intramammary Suspension for Lactating Cows
NOROCLAV SUSPENSION INTRAMAMARIA PARA VACAS EN LACTACION
Active substance:
  • Prednisolone
  • Potassium clavulanate
  • Amoxicillin trihydrate
Target species:
  • Cattle
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Prednisolone
    10.00
    milligram(s)
    /
    1.00
    Syringe
  • Potassium clavulanate
    59.56
    milligram(s)
    /
    1.00
    Syringe
  • Amoxicillin trihydrate
    229.61
    milligram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle
      • Meat and offal
        7
        day
      • Meat and offal
        42
        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:
  • Spain
Package description:
  • Single dose 3g white LDPE syringes with a white LDPE dual push-fit cap.Buckets of 120 syringes, including 120 individually wrapped teat cleaning towels containing isopropyl alcohol.
  • Single dose 3g white LDPE syringes with a white LDPE dual push-fit cap.Cartons of 24 syringes, including 24 individually wrapped teat cleaning towels containing isopropyl alcohol.
  • Single dose 3g white LDPE syringes with a white LDPE dual push-fit cap.Cartons of 12 syringes, including 12 individually wrapped teat cleaning towels containing isopropyl alcohol.
  • Single dose 3g white LDPE syringes with a white LDPE dual push-fit cap.Cartons of 3 syringes, including 3 individually wrapped teat cleaning towels containing isopropyl alcohol.

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 Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3697 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0535/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Hungary
  • Italy
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 29/12/2024
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Spanish (PDF)
Published on: 4/02/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 4/02/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 4/02/2025
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Combined File of all Documents

English (PDF)
Published on: 29/12/2024
Download