Product identification
Medicine name:
Butagran Equi 200 mg/g Oral powder
Active substance:
- Phenylbutazone
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Phenylbutazone200.00/milligram(s)1.00gram(s)
Pharmaceutical form:
-
Oral powder
Withdrawal period by route of administration:
-
Oral use
-
Horse
-
Meat and offalno withdrawal periodNot for use in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Available in:
-
Denmark
Package description:
- Butagran Equi 200 mg/g 20 sachets (ALU/LDPE/paper/LDPE) of 5g or. pwdr.
- Butagran Equi 200 mg/g 100 sachet ((ALU/LDPE/paper/LDPE)) 5 g or. pwdr.)
- Butagran Equi 200 mg/g 20 sachet (PET/LDPE/ALU/LDPE) 5 g or. pwdr.
- Butagran Equi 200 mg/g 100 sachet (PET/LDPE/ALU/LDPE) 5 g or. pwdr.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 18 of Regulation (EU) 2019/6)
Manufacturing sites for batch release:
- Dopharma Research B.V.
Authorisation number:
- 49966
Date of authorisation status change:
Reference member state:
-
Belgium
Procedure number:
- BE/V/0035/001
Concerned member states:
-
Austria
-
Bulgaria
-
Denmark
-
Estonia
-
Germany
-
Italy
-
Latvia
-
Lithuania
-
Poland
-
Romania
-
Spain
-
United Kingdom (Northern Ireland)
Generic of:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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in another language below.
Danish (PDF)
Published on: 29/06/2023