Veterinary Medicines

MODULIS 100 MG/ML ORAL SOLUTION FOR DOGS

Authorised
  • Ciclosporin
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Product identification

Medicine name:
MODULIS 100 MG/ML ORAL SOLUTION FOR DOGS
Modulis 100 mg/ml Lösung zum Eingeben für Hunde
Active substance:
  • Ciclosporin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ciclosporin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QL04AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:

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:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Laboratoires Biove
  • Ceva Sante Animale
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 835947
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0339/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 3/08/2022
Updated on: 3/10/2024
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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.
German (PDF)
Published on: 16/08/2023
Updated on: 3/10/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 24/10/2019
Updated on: 3/10/2024
Download

Combined File of all Documents

English (PDF)
Published on: 18/03/2025
Download
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