Veterinary Medicines

Isaderm vet, Gel

Authorised
  • Betamethasone valerate
  • Fusidic acid hemihydrate
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Product identification

Medicine name:
Isaderm vet, Gel
ISADERM
Active substance:
  • Betamethasone valerate
  • Fusidic acid hemihydrate
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Betamethasone valerate
    1.21
    milligram(s)
    /
    1.00
    gram(s)
  • Fusidic acid hemihydrate
    5.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Gel
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QD07CC01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • Tube, 30 g
  • Tube, 15 g
  • Tube, 10 x 15 g

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Veterinary Products A/S
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 1544 ESP
Date of authorisation status change:
Reference member state:
  • Sweden
Procedure number:
  • SE/V/0101/001
Concerned member states:
  • Greece
  • Italy
  • Portugal
  • Spain

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 22/02/2023
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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: 22/02/2023
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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: 22/02/2023
Download
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