Veterinary Medicines

EKYFLOGYL 1.8 MG/ML + 8.7 MG/ML GEL FOR HORSES

Authorised
  • Prednisolone acetate
  • Lidocaine hydrochloride monohydrate
Download as PDF

Product identification

Medicine name:
EKYFLOGYL 1.8 MG/ML + 8.7 MG/ML GEL FOR HORSES
Ekyflogyl 1,8 mg/ml + 8,7 mg/ml gel para cavalos
Active substance:
  • Prednisolone acetate
  • Lidocaine hydrochloride monohydrate
Target species:
  • Horse
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Prednisolone acetate
    2.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Lidocaine hydrochloride monohydrate
    10.70
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Gel
Withdrawal period by route of administration:
  • Cutaneous use
    • Horse
      • Meat and offal
        10
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM02AX99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:

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:
  • Audevard
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma France S.A.S.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1290/01/19DFVPT
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0344/001
Concerned member states:
  • Austria
  • Denmark
  • Finland
  • Germany
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 4/04/2024
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."