Veterinary Medicines

Revertor 5 mg/ml Solution for Injection for Dogs and Cats

Authorised
  • Atipamezole hydrochloride
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Product identification

Medicine name:
Revertor 5 mg/ml Solution for Injection for Dogs and Cats
Revertor Vet. 5 mg/ml injektionsvæske, opløsning
Active substance:
  • Atipamezole hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Atipamezole hydrochloride
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QV03AB90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • (ID3) 100 millilitre(s): unspecified outer container with 10 Vial each with 10 millilitre(s)
  • (ID2) 50 millilitre(s): unspecified outer container with 5 Vial each with 10 millilitre(s)
  • (ID1) 10 millilitre(s): unspecified outer container with 1 Vial with 10 millilitre(s)

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:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 41781
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0123/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Danish (, INJEKTIONSVÆSKE, OPLØSNING 5 MG-ML)
Published on: 29/06/2023
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