Veterinary Medicine Information website

Subestin 25 microgram/ml oral solution for horses

Authorised
  • Clenbuterol hydrochloride
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Product identification

Medicine name:
Subestin 25 microgram/ml oral solution for horses
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:
  • Oral solution
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:
  • Sweden
Package description:
  • White HDPE bottle with white polypropylene child-resistant screw cap and LDPE syringe inlay. The product is supplied in a carton box with a measuring device, a 25 ml syringe with polypropylene body and polyethylene plunger, capable of delivering 4 to 24 ml of the product. Each bottle contains 360 ml.

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:
  • Floris Holding B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Floris Veterinaire Producten B.V.
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 62633
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0362/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 15/12/2025
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 5/12/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 28/07/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 28/07/2025
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Final PuAR_Subestin NLV0362001_122025.pdf

English (PDF)
Published on: 15/12/2025
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