Veterinary Medicines

Sporimune 50 mg/ml oral solution for cats and dogs

Authorised
  • Ciclosporin
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Product identification

Medicine name:
Sporimune 50 mg/ml oral solution for cats and dogs
SPORIMUNE 50 mg/ml SOLUCION ORAL PARA GATOS Y PERROS
Active substance:
  • Ciclosporin
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ciclosporin
    50.00
    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:
  • Spain
Package description:
  • Brown glass bottles (type III) of 25 ml, closed with a child resistant closure (PP screw cap with a Teflon inlay).One bottle and a dispenser set (consisting of a child resistant HDPE screw cap and a 1 ml PP dosing syringe for cats and a 5 ml PP dosing syringe for dogs) packed in a cardboard box.
  • Brown glass bottles (type III) of 50 ml, closed with a child resistant closure (PP screw cap with a Teflon inlay).One bottle and a dispenser set (consisting of a child resistant HDPE screw cap and a 1 ml PP dosing syringe for cats and a 5 ml PP dosing syringe for dogs) packed in a cardboard box.
  • Brown glass bottles (type III) of 100 ml, closed with a child resistant closure (PP screw cap with a Teflon inlay).One bottle and a dispenser set (consisting of a child resistant HDPE screw cap and a 1 ml PP dosing syringe for cats and a 5 ml PP dosing syringe for dogs) packed in a cardboard box.

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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2903 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0302/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 16/01/2026
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Spanish (PDF)
Published on: 5/02/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 5/02/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 5/02/2025
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Combined File of all Documents

English (PDF)
Published on: 19/01/2025
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