Atipam 5.0 mg/ml solution for injection for Cats and Dogs - atipamezole hydrochloride
Atipam 5.0 mg/ml solution for injection for Cats and Dogs - atipamezole hydrochloride
Authorised
- Atipamezole hydrochloride
Product identification
Medicine name:
Atipam 5.0 mg/ml solution for injection for Cats and Dogs - atipamezole hydrochloride
Atipam 5 mg/ml Oplossing voor injectie
Atipam 5 mg/ml Solution injectable
Atipam 5 mg/ml Injektionslösung
Active substance:
- Atipamezole hydrochloride
Target species:
-
Dog
-
Cat
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Atipamezole hydrochloride5.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Dog
-
Cat
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QV03AB90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Cardboard box with 1 clear glass type I vial of 20 ml, with a teflon coated halogenated rubber stopper and aluminium cap
- Cardboard box with 1 clear glass type I vial of 10 ml, with a teflon coated halogenated rubber stopper and aluminium cap
- Cardboard box with 1 clear glass type I vial of 5 ml, with a teflon coated halogenated rubber stopper and aluminium cap
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:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Eurovet Animal Health B.V.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V315542
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0279/001
Concerned member states:
-
Austria
-
Belgium
-
Czechia
-
Denmark
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Norway
-
Poland
-
Portugal
-
Slovakia
-
Slovenia
-
Spain
-
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: 7/06/2022
Summary of Product Characteristics
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Package Leaflet
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Labelling
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in another language below.
Atipam 5.0 mg.ml.pdf
English (PDF)
Download Published on: 2/06/2022
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