Veterinary Medicines

Apovomin 1 mg/ml solution for injection for dogs

Authorised
  • Apomorphine hydrochloride hemihydrate
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Product identification

Medicine name:
Apovomin 1 mg/ml solution for injection for dogs
APOVOMIN 1 mg/ml SOLUCION INYECTABLE PARA PERROS
Active substance:
  • Apomorphine hydrochloride hemihydrate
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Apomorphine hydrochloride hemihydrate
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN04BC07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • Clear Type I glass vials containing 5 ml, closed with a coated Type I bromobutyl rubber stopper and sealed with an aluminium cap. Each vial is packed into a cardboard box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) 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:
  • (AEMPS)
Authorisation number:
  • 3970 ESP
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0343/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/03/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/03/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/03/2023
Download
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