Veterinary Medicines

CEVAMULINE 125 MG/ML, ORAL SOLUTION FOR USE IN DRINKING WATER FOR RABBITS

Authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
CEVAMULINE 125 MG/ML, ORAL SOLUTION FOR USE IN DRINKING WATER FOR RABBITS
CEVAMULINE SOLUTION LAPIN
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Rabbit
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Tiamulin hydrogen fumarate
    125.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Rabbit
      • Meat and offal
        2
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Box containing 1 vial of 10 ml
  • 5 litre bottle
  • 2 litre bottle
  • 1 litre bottle
  • 500 ml bottle
  • Box containing 1 vial of 100 ml
  • Box containing 1 vial of 30 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/9392718 9/2009
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0261/001
Concerned member states:
  • Italy

Documents

Summary of Product Characteristics

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French (PDF)
Published on: 1/07/2025
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