Veterinary Medicines

Prevomax 10 mg/ml - Solution for injection

Authorised
  • Maropitant
Download as PDF

Product identification

Medicine name:
Prevomax 10 mg/ml - Solution for injection
Active substance:
  • Maropitant
Target species:
  • Dog
  • Cat
Route of administration:
  • Intravenous use
  • Subcutaneous use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Maropitant
    10.00
    milligram(s)
    /
    1.00
    Vial
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Dog
    • Cat
  • Subcutaneous use
    • Dog
    • Cat
  • 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:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Package description:
  • Packaging:Vial (glass), Package_size:1 vial, Content:50 ml
  • Packaging:Vial (glass), Package_size:1 vial, Content:10 ml
  • Packaging:Vial (glass), Package_size:1 vial, Content:25 ml
  • Packaging:Vial (glass), Package_size:1 vial, Content:20 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.
  • Eurovet Animal Health B.V.
Responsible authority:
  • European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

English (PDF)
Published on: 1/02/2024
Download
Bulgarian (PDF)
Published on: 1/02/2024
Download
Croatian (PDF)
Published on: 1/02/2024
Download
Czech (PDF)
Published on: 1/02/2024
Download
Danish (PDF)
Published on: 1/02/2024
Download
Dutch (PDF)
Published on: 1/02/2024
Download
Estonian (PDF)
Published on: 1/02/2024
Download
Finnish (PDF)
Published on: 1/02/2024
Download
French (PDF)
Published on: 1/02/2024
Download
German (PDF)
Published on: 1/02/2024
Download
Greek (PDF)
Published on: 1/02/2024
Download
Hungarian (PDF)
Published on: 1/02/2024
Download
Icelandic (PDF)
Published on: 1/02/2024
Download
Italian (PDF)
Published on: 1/02/2024
Download
Latvian (PDF)
Published on: 1/02/2024
Download
Lithuanian (PDF)
Published on: 1/02/2024
Download
Maltese (PDF)
Published on: 1/02/2024
Download
Norwegian (PDF)
Published on: 1/02/2024
Download
Polish (PDF)
Published on: 1/02/2024
Download
Portuguese (PDF)
Published on: 1/02/2024
Download
Romanian (PDF)
Published on: 1/02/2024
Download
Slovak (PDF)
Published on: 1/02/2024
Download
Slovenian (PDF)
Published on: 1/02/2024
Download
Spanish (PDF)
Published on: 1/02/2024
Download
Swedish (PDF)
Published on: 1/02/2024
Download

ema-puar-prevomax-v-4331-par-en.pdf

English (PDF)
Published on: 15/03/2023
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."