Veterinary Medicines

DOPHATYL-JECT 200 000 IU/ML SOLUTION FOR INJECTION FOR CATTLE, SHEEP, GOATS AND PIGS

Authorised
  • Tylosin
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Product identification

Medicine name:
DOPHATYL-JECT 200 000 IU/ML SOLUTION FOR INJECTION FOR CATTLE, SHEEP, GOATS AND PIGS
Tilsing Vet. 200.000 IE/ml injektionsvæske, opløsning
Active substance:
  • Tylosin
Target species:
  • Cattle
  • Pig
  • Sheep
  • Goat
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Tylosin
    200000.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        108
        hour
    • Pig
      • Meat and offal
        16
        day
    • Sheep
      • Meat and offal
        42
        day
      • Milk
        108
        hour
    • Goat
      • Meat and offal
        42
        day
      • Milk
        108
        hour
  • Intravenous use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        108
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • Cardboard box with 1 colourless, type I glass vial of 100 ml, closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
  • Cardboard box with 1 colourless, type I glass vial of 50 ml, closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 69515
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0477/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden
Generic of:

Documents

Summary of Product Characteristics

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Danish (000 IE-ML)
Published on: 5/05/2025
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