Veterinary Medicines

Vominil 10 mg/ml Injektionslösung für Hunde und Katzen

Authorised
  • Maropitant citrate monohydrate
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Product identification

Medicine name:
Vominil 10 mg/ml Injektionslösung für Hunde und Katzen
Vominil 10 mg/ml oplossing voor injectie voor honden en katten
Active substance:
  • Maropitant citrate monohydrate
Target species:
  • Dog
  • Cat
Route of administration:
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Maropitant citrate monohydrate
    14.48
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Dog
    • Cat
  • Subcutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA04AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • Amber glass vial type I (Ph. Eur.) with 10 ml solution for injection, closed with a chlorobutyl rubber stopper, type I (Ph. Eur) and aluminium pull or flip off cap in a cardboard box.
  • Amber glass vial type I (Ph. Eur.) with 25 ml solution for injection, closed with a chlorobutyl rubber stopper, type I (Ph. Eur) and aluminium pull or flip off cap in a cardboard box.
  • Amber glass vial type I (Ph. Eur.) with 50 ml solution for injection, closed with a chlorobutyl rubber stopper, type I (Ph. Eur) and aluminium pull or flip off cap in a cardboard box.
  • 5 x Amber glass vials type I (Ph. Eur.) with 10 ml solution for injection, closed with a chlorobutyl rubber stopper, type I (Ph. Eur) and aluminium pull or flip off cap in a cardboard box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetviva Richter GmbH
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 130116
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0030/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 28/08/2023
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Dutch (PDF)
Published on: 30/08/2023
Updated on: 1/09/2023
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