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 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 hemihydrate
    3.00
    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:
  • 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)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."