Veterinary Medicines

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

Authorised
  • Prednisolone acetate
  • Lidocaine hydrochloride monohydrate
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Product identification

Medicine name:
EKYFLOGYL 1.8 MG/ML + 8.7 MG/ML GEL FOR HORSES
Ekyflogyl 1,8+8,7 mg/ml gel
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:
  • Denmark
Package description:
  • Box of one 125 ml Brown Type III glass bottle with a dosing pump made of high-density polyethylene / polypropylene and a dip tube made of low-density polyethylene and polypropylene. Polypropylene screw-fit cap.

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
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 61449
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0344/001
Concerned member states:
  • Austria
  • Denmark
  • Finland
  • Germany
  • Ireland
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Sweden

Documents

Summary of Product Characteristics

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Danish (PDF)
Published on: 24/06/2024
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