Veterinary Medicines

Trovex 1 mg/ml suspension for injection for cattle, horses, pigs, cats and dogs

Authorised
  • Dexamethasone isonicotinate
Download as PDF

Product identification

Medicine name:
Trovex 1 mg/ml suspension for injection for cattle, horses, pigs, cats and dogs
Active substance:
  • Dexamethasone isonicotinate
Target species:
  • Cattle
  • Dog
  • Horse
  • Cat
  • Pig
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Dexamethasone isonicotinate
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        55
        day
      • Milk
        60
        hour
    • Dog
    • Horse
      • Meat and offal
        63
        day
    • Cat
    • Pig
      • Meat and offal
        55
        day
  • Subcutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • One amber, glass (Ph. Eur. Type I or Ph. Eur. siliconized Type II) multidose vial containing 50 ml of product, sealed with a grey siliconized bromobutyl rubber stopper and aluminium cap, in a cardboard box Pack sizes: Cardboard box containing 1 vial of 50 ml

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:
  • Emdoka
Marketing authorisation date:
Manufacturing sites for batch release:
  • Divasa Farmavic S.A.
Responsible authority:
  • VMD
Authorisation number:
  • VM 34534/4008
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0517/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."