Veterinary Medicines

HYDROTRIM 500 MG/G + 100 MG/G POWDER FOR USE IN DRINKING WATER/MILK FOR CATTLE, SHEEP, PIGS AND CHICKENS

Authorised
  • Sulfadiazine sodium
  • Trimethoprim
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Product identification

Medicine name:
HYDROTRIM 500 MG/G + 100 MG/G POWDER FOR USE IN DRINKING WATER/MILK FOR CATTLE, SHEEP, PIGS AND CHICKENS
Hydrotrim 500+100 mg/g pulver til anvendelse i drikkevand/mælk
Active substance:
  • Sulfadiazine sodium
  • Trimethoprim
Target species:
  • Cattle (pre-ruminant)
  • Sheep (lamb)
  • Chicken
  • Pig
Route of administration:
  • In drinking water/milk use
  • In drinking water use

Product details

Active substance and strength:
  • Sulfadiazine sodium
    543.90
    milligram(s)
    /
    1.00
    gram(s)
  • Trimethoprim
    100.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water/milk
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Cattle (pre-ruminant)
      • Meat and offal
        12
        day
    • Sheep (lamb)
      • Meat and offal
        12
        day
  • In drinking water use
    • Chicken
      • Eggs
        no withdrawal period
      • Meat and offal
        12
        day
    • Pig
      • Meat and offal
        12
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • 1 kg resealable block -bottom zipped sachet made of polyethylene/aluminium/polyethylene terephthalate laminate.
  • 100 g pillow sachet made of polyethylene/aluminium/polyethylene terephthalate laminate.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • HuVepharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biovet AD
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 67816
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0457/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Summary of Product Characteristics

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Danish (PDF)
Published on: 9/10/2023
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