Apovomin 3 mg/ml solution for injection for dogs
Apovomin 3 mg/ml solution for injection for dogs
Authorised
- Apomorphine hydrochloride hemihydrate
Product identification
Medicine name:
Apovomin 3 mg/ml solution for injection for dogs
Apovomin 3 mg/ml Oplossing voor injectie
Apovomin 3 mg/ml Solution injectable
Apovomin 3 mg/ml Injektionslösung
Active substance:
- Apomorphine hydrochloride hemihydrate
Target species:
-
Dog
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Apomorphine hydrochloride hemihydrate3.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN04BC07
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Clear Type I glass vial containing 10ml, closed with a coated bromobutyl rubber stopper and sealed with analuminium cap. Each vial is packed into a cardboard box.Pack size:Multi-pack with 10 vials of 10 ml
- Clear Type I glass vial containing 5ml, closed with a coated bromobutyl rubber stopper and sealed with analuminium cap. Each vial is packed into a cardboard box.Pack size:Multi-pack with 10 vials of 5 ml
- Clear Type I glass vial containing 20 ml, closed with a coated bromobutyl rubber stopper and sealed with analuminium cap. Each vial is packed into a cardboard box.Pack size:Box with 1 vial of 20 ml
- Clear Type I glass vial containing 10ml, closed with a coated bromobutyl rubber stopper and sealed with analuminium cap. Each vial is packed into a cardboard box.Pack size:Box with 1 vial of 10 ml
- Clear Type I glass vial containing 5ml, closed with a coated bromobutyl rubber stopper and sealed with analuminium cap. Each vial is packed into a cardboard box.Pack size:Box with 1 vial of 5 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:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- PRODULAB PHARMA B.V.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V539306
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0482/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Combined File of all Documents
English (PDF)
Download Published on: 6/07/2025
Labelling
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