Veterinary Medicines

Apovomin 3 mg/ml solution for injection for dogs

Authorised
  • Apomorphine hydrochloride hemihydrate
Download as PDF

Product identification

Medicine name:
Apovomin 3 mg/ml solution for injection for dogs
Apovomin, 3mg/ml, Injekční roztok
Active substance:
  • Apomorphine hydrochloride hemihydrate
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Apomorphine hydrochloride hemihydrate
    3.00
    milligram(s)
    /
    1.00
    millilitre(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:
  • Czechia
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:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/005/19-C
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)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 19/12/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 19/12/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 19/12/2025
Download

Combined File of all Documents

English (PDF)
Published on: 6/07/2025
Download