BUPROXAN MULTIDOSE 0.3 MG/ML SOLUTION FOR INJECTION FOR DOGS, CATS AND HORSES
BUPROXAN MULTIDOSE 0.3 MG/ML SOLUTION FOR INJECTION FOR DOGS, CATS AND HORSES
Authorised
- Buprenorphine hydrochloride
Product identification
Medicine name:
BUPROXAN MULTIDOSE 0.3 MG/ML SOLUTION FOR INJECTION FOR DOGS, CATS AND HORSES
Active substance:
- Buprenorphine hydrochloride
Target species:
-
Dog
-
Cat
-
Horse (non food-producing)
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Buprenorphine hydrochloride0.32/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
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Horse (non food-producing)
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Not applicableno withdrawal periodNot to be used 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:
- QN02AE01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Netherlands
Package description:
- Clear colourless glass vial, 10 ml, Type I
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Alfasan Nederland B.V.
Responsible authority:
- Medicines Evaluation Board
Authorisation number:
- REG NL 134875
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0520/001
Concerned member states:
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Austria
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Belgium
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Bulgaria
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Croatia
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Cyprus
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Czechia
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Denmark
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Estonia
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Finland
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Germany
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Greece
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Hungary
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Iceland
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Ireland
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Italy
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Latvia
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Lithuania
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Luxembourg
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Netherlands
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Norway
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Poland
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Portugal
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Romania
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Slovakia
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Spain
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Sweden
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United Kingdom (Northern Ireland)
Generic of:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
