Veterinary Medicines

Cosacthen 0.25 mg/ml solution for injection for dogs

Authorised
  • Tetracosactide hexaacetate
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Product identification

Medicine name:
Cosacthen 0.25 mg/ml solution for injection for dogs
Active substance:
  • Tetracosactide hexaacetate
Target species:
  • Dog
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Tetracosactide hexaacetate
    0.28
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
  • Intravenous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Luxembourg
Package description:
  • Type I clear glass vial with a coated rubber stopper and aluminium seal packed in a cardboard box.Pack size: 1 ml vial per box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • Ministere De La Sante Division De La Pharmacie Et Des Medicaments
Authorisation number:
  • V 914/20/04/2078
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0461/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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