Veterinary Medicines

DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Authorised
  • Doramectin
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Product identification

Medicine name:
DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs
DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs
Active substance:
  • Doramectin
Target species:
  • Sheep
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Doramectin
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Sheep
      • Meat and offal
        70
        day
    • Pig
      • Meat and offal
        77
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        70
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • The product is supplied in 250 ml multi-dose Type II amber glass vials with chlorobutyl rubber stoppers and aluminium overcaps.
  • The product is supplied in 500 ml multi-dose Type II amber glass vials with chlorobutyl rubber stoppers and aluminium overcaps.
  • The product is supplied in 200 ml multi-dose Type II amber glass vials with chlorobutyl rubberstoppers and aluminium overcaps.
  • The product is supplied in 50 ml multi-dose Type II amber glass vials with chlorobutyl rubber stoppers and aluminium overcaps.
  • The product is supplied in 50 ml multi-dose Type III amber glass vials with chlorobutyl rubber stoppers and aluminium overcaps.
  • The product is supplied in 200 ml multi-dose Type III amber glass vials with chlorobutyl rubberstoppers and aluminium overcaps.
  • The product is supplied in 500 ml multi-dose Type III amber glass vials with chlorobutyl rubber stoppers and aluminium overcaps.

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:
  • Zoetis Belgium S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10387/019/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0260/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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