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 25 mikrogramov/ml sirup pre kone
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:
  • Slovakia
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:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/069/DC/12-S
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 3/06/2024
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Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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