Veterinary Medicines

Dilaterol 25 micrograms/ml syrup for horses

Authorised
  • Clenbuterol hydrochloride
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Product identification

Medicine name:
Dilaterol 25 micrograms/ml syrup for horses
Dilaterol Vet. 25 mikrogram/ml syrup
Active substance:
  • Clenbuterol hydrochloride
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Clenbuterol hydrochloride
    25.00
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Syrup
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        28
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QR03CC13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • 355 ml HDPE bottle sealed with an aluminium/PE heat seal or a transparent HDPE cap. The product is supplied in a carton box with a multi-component mechanical pump dispenser capable of delivering 4 ml of the product.

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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 49677
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0619/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Hungary
  • Iceland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Danish (, SYRUP 25 MIKROG-ML)
Published on: 19/08/2024
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