Veterinary Medicines

EMEDOG, 1 MG/ML, SOLUTION FOR INJECTION FOR DOGS

Authorised
  • Apomorphine hydrochloride hemihydrate
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Product identification

Medicine name:
EMEDOG, 1 MG/ML, SOLUTION FOR INJECTION FOR DOGS
Emedog 1 mg/ml injektionsvæske, opløsning
Active substance:
  • Apomorphine hydrochloride hemihydrate
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Apomorphine hydrochloride hemihydrate
    1.17
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN04BC07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • Cardboard box of 5 colourless glass ampoules type I of 1 ml
  • Cardboard box of 20 colourless glass ampoules type I of 1 ml.

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:
  • Domes Pharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Haupt Pharma Livron
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 69078
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0281/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 13/06/2023
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