Equipalazone 1 g Oral powder
Equipalazone 1 g Oral powder
Authorised
- Phenylbutazone
Product identification
Medicine name:
Fenylbutazon Dechra Vet 1 g pulver til hest og ponni
Equipalazone 1 g Oral powder
Active substance:
- Phenylbutazone
Target species:
-
Horse (pony)
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Phenylbutazone1.00/gram(s)1.00Sachet
Pharmaceutical form:
-
Oral powder
Withdrawal period by route of administration:
-
Oral use
-
Horse (pony)
-
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.
-
-
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
Authorised in:
-
Norway
Package description:
- Equipalazone 1 g or. pwdr. sachet 100
- Equipalazone 1 g or. pwdr. sachet 32
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Genera d.d.
Responsible authority:
- Norwegian Medical Products Agency
Authorisation number:
- 16-11233
Date of authorisation status change:
Reference member state:
-
Belgium
Procedure number:
- BE/V/0037/001
Concerned member states:
-
Austria
-
Norway
-
Poland
-
Portugal
-
Slovakia
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
Norwegian (PDF)
Published on: 20/11/2024
Summary of Product Characteristics
This document does not exist in this language (English). You can find it
in another language below.
Norwegian (PDF)
Published on: 20/11/2024
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