Veterinary Medicines

Ancesol 10 mg/ml solution for injection for cattle

Authorised
  • Chlorphenamine maleate
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Product identification

Medicine name:
Ancesol 10 mg/ml solution for injection for cattle
Ancesol 10 mg/ml Injektionslösung für Rinder
Active substance:
  • Chlorphenamine maleate
Target species:
  • Cattle
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Chlorphenamine maleate
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        12
        hour
  • Intramuscular use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        12
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QR06AB04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • Amber glass 5 vial 100 ml, type II (Ph.Eur.) with bromobutyl-rubber stopper type I (Ph.Eur.) and aluminium cap in a cardboard box
  • Amber glass 1 vial 100 ml , type II (Ph.Eur.) with bromobutyl-rubber stopper type I (Ph.Eur.) and aluminium cap in a cardboard box

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:
  • Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Richter Pharma AG
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402076.00.00
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0131/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 16/02/2022
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