Cosacthen 0.25 mg/ml solution for injection for dogs
Cosacthen 0.25 mg/ml solution for injection for dogs
Authorised
- Tetracosactide hexaacetate
Product identification
Medicine name:
Cosacthen 0.25 mg/ml solution for injection for dogs
Cosacthen 0.25 mg/ml Oplossing voor injectie
Cosacthen 0.25 mg/ml Solution injectable
Cosacthen 0.25 mg/ml Injektionslösung
Active substance:
- Tetracosactide hexaacetate
Target species:
-
Dog
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Tetracosactide hexaacetate0.28/milligram(s)1.00millilitre(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:
-
Belgium
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:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V557920
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Combined File of all Documents
English (PDF)
Download Published on: 22/12/2024
Labelling
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