Subestin 25 microgram/ml oral solution for horses
Subestin 25 microgram/ml oral solution for horses
Authorised
- Clenbuterol hydrochloride
Product identification
Medicine name:
Subestin 25 microgram/ml oral solution for horses
Subestin 25 µg/ml orale oplossing
Subestin 25 µg/ml Solution buvable
Subestin 25 µg/ml Lösung zum Eingeben
Active substance:
- Clenbuterol hydrochloride
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Clenbuterol hydrochloride25.00/microgram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral solution
Withdrawal period by route of administration:
-
Oral use
-
Horse
-
Meat and offal28dayNot authorised for use in animals producing milk for human consumption
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QR03CC13
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
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:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V598951
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 15/12/2025
Package Leaflet
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Summary of Product Characteristics
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Labelling
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Final PuAR_Subestin NLV0362001_122025.pdf
English (PDF)
Download Published on: 15/12/2025
