Veterinary Medicines

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

Authorised
  • Dexamethasone isonicotinate
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Product identification

Medicine name:
Trovex 1 mg/ml suspension for injection for cattle, horses, pigs, cats and dogs
Trovex 1 mg/ml suspenzija za injiciranje za govedo, konje, prašiče, mačke in pse
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:
  • Slovenia
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 boxPack 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:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0744/001
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: 5/10/2025
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Slovenian (PDF)
Published on: 8/10/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 8/10/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 8/10/2025
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Combined File of all Documents

English (PDF)
Published on: 5/10/2025
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