Veterinary Medicines

Evomate RTU 400 mg/ml

Authorised
  • Penethamate hydriodide
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Product identification

Medicine name:
Evomate RTU 400 mg/ml
Revozyn RTU 400 mg/ml Suspensie voor injectie
Revozyn RTU 400 mg/ml Suspension injectable
Revozyn RTU 400 mg/ml Injektionssuspension
Active substance:
  • Penethamate hydriodide
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Penethamate hydriodide
    400.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        4
        day
      • Meat and offal
        10
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CE90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Multidose 50 ml uncoloured glass (type II, Ph. Eur.) vial, closed with a fluoropolymer coated rubber type I (Ph. Eur.) stopper, secured with an aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
  • Produlab Pharma B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V531537
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0229/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • France
  • Hungary
  • Ireland
  • Italy
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 6/01/2023
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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: 13/08/2025
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French (PDF)
Published on: 13/08/2025
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German (PDF)
Published on: 13/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 13/08/2025
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French (PDF)
Published on: 13/08/2025
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German (PDF)
Published on: 13/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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