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 VET 1,8 mg/ml + 8,7 mg/ml GEL TIL HESTER
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:
  • Norway
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:
  • Norwegian Medical Products Agency
Authorisation number:
  • 18-12373
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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 18/03/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 18/03/2024
Download
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