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 SOLUTION BUVABLE POUR CHIENS
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QL04AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
Package description:
  • Box of one 5 mL vial and one 1 mL graduated syringe for oral administration
  • Box of one 50 mL vial and one 2 mL graduated syringe for oral administration
  • Box of one 30 mL vial and one 2 mL graduated syringe for oral administration
  • Box of one 15 mL vial and one 1 mL graduated syringe for oral administration

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 Santé Animale
  • Laboratoires Biove
  • Ceva Sante Animale
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/0321650 5/2014
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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 10/10/2025
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 15/10/2025
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Combined File of all Documents

English (PDF)
Published on: 30/09/2025
Download