Veterinary Medicines

Histodine

Authorised
  • Chlorphenamine maleate
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Product identification

Medicine name:
Histodine
Histodine 10 mg/ml stungulyf, lausn handa nautgripum
Active substance:
  • Chlorphenamine maleate
Target species:
  • Cattle
Route of administration:
  • Intramuscular use
  • Intravenous 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:
  • Intramuscular use
    • Cattle
      • Milk
        12
        hour
      • Meat and offal
        1
        day
  • Intravenous use
    • Cattle
      • Milk
        12
        hour
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QR06AB04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Iceland
Package description:
  • 250 ml polypropylene vial, closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box
  • 100 ml polypropylene vial, closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box
  • 250 ml clear Type II glass vial, closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box
  • 100 ml clear Type II glass vial, closed with a coated bromobutyl rubber stopper and aluminium cap in a carton 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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Icelandic Medicines Agency
Authorisation number:
  • IS/2/17/003/01
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0211/001
Concerned member states:
  • Belgium
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 23/05/2022
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