Veterinary Medicine Information website

VETEGLAN 0.075 mg/ml Solution for injection for cows, sows and mares

Authorised
  • Cloprostenol sodium
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Product identification

Medicine name:
VETEGLAN 0.075 mg/ml Solution for injection for cows, sows and mares
Active substance:
  • Cloprostenol sodium
Target species:
  • Cattle (cow)
  • Pig
  • Horse (mare)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Cloprostenol sodium
    0.08
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        1
        day
    • Horse (mare)
      • Meat and offal
        2
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • 20 ml amber coloured Type I glass vials, with Teflon-coated chlorobutyl rubber closures and aluminium seals with blue coloured plastic flip-offs, packaged singly in a cardboard box.
  • 10 ml amber coloured Type I glass vials, with Teflon-coated chlorobutyl rubber closures and aluminium seals with blue coloured plastic flip-offs, packaged singly in a cardboard box.

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:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 220033
Date of authorisation status change:
Reference member state:
  • Portugal
Procedure number:
  • PT/V/0100/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Latvia
  • Lithuania
  • Netherlands
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 23/07/2024
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