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Cepesedan RP 10 mg/ml, Solution for Injection for Horses and Cattle

Authorised
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
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Product identification

Medicine name:
Cepesedan RP 10 mg/ml, Solution for Injection for Horses and Cattle
Active substance:
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
Target species:
  • Cattle
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        2
        day
      • Milk
        12
        hour
    • Horse
      • Meat and offal
        2
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        2
        day
      • Milk
        12
        hour
    • Horse
      • Meat and offal
        2
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • (ID4) 100 millilitre(s): unspecified outer container with 5 Vial (Glass) each with 20 millilitre(s), closed with Stopper and Cap (bromobutyl rubber`, Aluminium)
  • (ID3) 25 millilitre(s): unspecified outer container with 5 Vial (Glass) each with 5 millilitre(s), closed with Cap and Stopper (Aluminium, bromobutyl rubber`)
  • (ID2) 20 millilitre(s): unspecified outer container with 1 Vial (Glass) with 20 millilitre(s), closed with Stopper and Cap (bromobutyl rubber`, Aluminium)
  • (ID1) 5 millilitre(s): unspecified outer container with 1 Vial (Glass) with 5 millilitre(s), closed with Cap and Stopper (Aluminium, bromobutyl rubber`)

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:
  • 40351
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0117/001
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

This document does not exist in this language (English). You can find it in another language below.
Danish (, INJEKTIONSVÆSKE, OPLØSNING 10 MG-ML)
Published on: 29/06/2023
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