Veterinary Medicines

Ubropen 600 mg intramammary suspension for lactating cows

Authorised
  • Benzylpenicillin procaine monohydrate
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Product identification

Medicine name:
Carepen vet 600 mg intramammary suspension for lactating cows
Ubropen 600 mg intramammary suspension for lactating cows
Active substance:
  • Benzylpenicillin procaine monohydrate
Target species:
  • Cattle (lactating cow)
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Benzylpenicillin procaine monohydrate
    600.00
    milligram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle (lactating cow)
      • Meat and offal
        3
        day
      • Milk
        6
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ51CE09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Pack size: 100 x 10 g with 100 cleaning towels. White intramammary syringe (LDPE) with a double tip (LDPE) packed in a cardboard container.
  • Pack size: 40 x 10 g with 40 cleaning towels. White intramammary syringe (LDPE) with a double tip (LDPE) packed in a cardboard container.
  • Pack size: 20 x 10 g with 20 cleaning towels. White intramammary syringe (LDPE) with a double tip (LDPE) packed in a cardboard container.
  • Pack size: 5 x 10 g with 5 cleaning towels. White intramammary syringe (LDPE) with a double tip (LDPE) packed in a cardboard container.
  • Pack size: 3 x 10 g with 3 cleaning towels. White intramammary syringe (LDPE) with a double tip (LDPE) packed in a cardboard container.

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:
  • Vetcare Oy
Marketing authorisation date:
Manufacturing sites for batch release:
  • Animedica GmbH
  • Kela - Kempisch Laboratorium - Kela Laboratoria
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10832/002/001
Date of authorisation status change:
Reference member state:
  • Finland
Procedure number:
  • FI/V/0110/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • France
  • Germany
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 9/08/2023
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Package Leaflet

English (PDF)
Published on: 9/08/2023
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Labelling

English (PDF)
Published on: 9/08/2023
Download
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