Taurador 10 mg/ml Solution for Injection for cattle, sheep & pigs

Authorised

Doramectin

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Product identification

Medicine name:

Taurador 10 mg/ml Solution for Injection for cattle, sheep & pigs

Taurador 10 mg/ml solution injectable pour bovins, ovins et porcins

Taurador 10 mg/ml oplossing voor injectie voor runderen, schapen en varkens

Taurador 10 mg/ml Injektionslösung für Rinder, Schafe und Schweine

Active substance:

Doramectin

Target species:

Cattle
Sheep
Pig

Route of administration:

Subcutaneous use
Intramuscular 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:

Subcutaneous use
- Cattle
  - Meat and offal
    
    70
    
    day
  - Milk
    
    no withdrawal period
    
    Not authorised for use in animals producing milk for human consumption. Do not use in pregnant cows or heifers which are intended to produce milk for human consumption within 2 months of expected parturition.
Intramuscular use
- Sheep
  - Meat and offal
    
    70
    
    day
  - Milk
    
    no withdrawal period
    
    Not authorised for use in animals producing milk for human consumption. Do not use in pregnant ewes which are intended to produce milk for human consumption within 70 days of expected parturition.
- Pig
  - Meat and offal
    
    77
    
    day

Anatomical therapeutic chemical veterinary (ATCvet) codes:

QP54AA03

Legal status of supply:

Veterinary medicinal product subject to veterinary prescription

Authorisation status:

Valid

Authorised in:

Belgium

Package description:

(ID3) 500 millilitre(s): Behältnis (Plastic) with 1 Vial (Glass) with 500 millilitre(s), closed with Stopper and Lid (Rubber, Aluminium)
(ID2) 250 millilitre(s): Behältnis (Plastic) with 1 Vial (Glass) with 250 millilitre(s), closed with Lid and Stopper (Aluminium, Rubber)
(ID1) 100 millilitre(s): Behältnis (Plastic) with 1 Vial (Glass) with 100 millilitre(s), closed with Stopper and Lid (Rubber, Aluminium)

Additional information

Entitlement type:

Marketing Authorisation

Legal basis of product authorisation:

Generic application (Article 18 of Regulation (EU) 2019/6)

Marketing authorisation holder:

Norbrook Laboratories (Ireland) Limited

Marketing authorisation date:

4/02/2025

Manufacturing sites for batch release:

Norbrook Laboratories Limited
Norbrook Manufacturing Limited

Responsible authority:

Federal Agency For Medicines And Health Products

Authorisation number:

BE-V663863

Date of authorisation status change:

4/02/2025

Reference member state:

Germany

Procedure number:

DE/V/0345/001

Concerned member states:

Belgium
Czechia
France
Hungary
Ireland
Netherlands
Portugal
Romania
Slovakia
Spain

Generic of:

To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet

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