Veterinary Medicines

Cyclavance 100 mg/ml oral solution for dogs and cats

Authorised
  • Ciclosporin
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Product identification

Medicine name:
Cyclavance 100 mg/ml oral solution for dogs and cats
CYCLAVANCE 100 mg/ml SOLUCION ORAL PARA PERROS Y GATOS
Active substance:
  • Ciclosporin
Target species:
  • Dog
  • Cat
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
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QL04A
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • Amber glass (type III) bottles closed with a 20 mm bromobutyl stopper and an aluminum cap with flip-off.50 ml bottle, with two dispenser sets consisting of a polycarbonate dispenser capwith a silicone valve and both 1 ml and 3 ml polypropylene oral syringes graduated in increments of respectively 0.05 ml and 0.1 ml, packaged in a cardboard box.
  • Amber glass (type III) bottles closed with a 20 mm bromobutyl stopper and an aluminum cap with flip-off.30 ml bottle, with two dispenser sets consisting of a polycarbonate dispenser capwith a silicone valve and both 1 ml and 3 ml polypropylene oral syringes graduated in increments of respectively 0.05 ml and 0.1 ml, packaged in a cardboard box.
  • Amber glass (type III) bottles closed with a 20 mm bromobutyl stopper and an aluminum cap with flip-off.15 ml bottle with a dispenser set consisting of a polycarbonate dispenser cap with asilicone valve and a 1 ml polypropylene oral syringe graduated in increments of 0.05 mL, packaged in a cardboard box.
  • Amber glass (type III) bottles closed with a 20 mm bromobutyl stopper and an aluminum cap with flip-off.5 ml bottle with a dispenser set consisting of a polycarbonate dispenser cap with asilicone valve and a 1 ml polypropylene oral syringe graduated in increments of 0.05 ml, packaged in a cardboard box.
  • Amber glass (type III) bottles closed with a child resistant HDPE screw cap including aplastic adapter (HDPE).60 ml bottle, with two dispenser sets consisting of both 1 ml and 2 ml PE oralsyringes graduated in increments of respectively 0.05 ml and 0.1 ml, packaged in a cardboard box.
  • Amber glass (type III) bottles closed with a child resistant HDPE screw cap including aplastic adapter (HDPE).30 ml bottle, with two dispenser sets consisting of both 1 ml and 2 ml PE oralsyringes graduated in increments of respectively 0.05 ml and 0.1 ml, packaged in a cardboard box.
  • Amber glass (type III) bottles closed with a child resistant HDPE screw cap including aplastic adapter (HDPE).15 ml bottle, with a dispenser set consisting of a 1 ml PE oral syringe graduated inincrements of 0.05 ml, packaged in a cardboard box.
  • Amber glass (type III) bottles closed with a child resistant HDPE screw cap including aplastic adapter (HDPE).5 ml bottle, with a dispenser set consisting of a 1 ml PE oral syringe graduated inincrements of 0.05 ml, packaged 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:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 3011 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0523/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • 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: 3/05/2024
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Spanish (PDF)
Published on: 15/02/2024
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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: 15/02/2024
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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: 15/02/2024
Download
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