Veterinary Medicines

Medesedan 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
Medesedan 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:
  • Ireland
Available in:
  • Ireland
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:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10810/003/001
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

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