Tulaven

RSS

tulathromycin

Authorised
This medicine is authorised for use in the European Union.

Overview

Tulaven is an antibiotic medicine that is used to treat the following diseases if they are caused by bacteria that are susceptible to it:

  • bovine respiratory disease (BRD) in cattle caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis;
  • infectious bovine keratoconjunctivitis (IBK) in cattle, an eye disease caused by Moraxella bovis;
  • swine respiratory disease (SRD) in pigs caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica;
  • early stages of foot rot in sheep caused by Dichelobacter nodosus, which requires treatment with a medicine given by mouth or by injection.

Tulaven can also be used for metaphylaxis of BRD and SRD. This involves treating at the same time both diseased animals and healthy animals in close contact with them, to prevent further spread of the disease. The medicine should only be used for metaphylaxis in cattle and pigs once presence of the disease in the herd has been established.

Tulaven contains the active substance tulathromycin.

Tulaven is a ‘generic medicine’. This means that Tulaven contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Draxxin.

For more information, see the package leaflet.

This EPAR was last updated on 26/06/2020

Authorisation details

Product details
Name
Tulaven
Agency product number
EMEA/V/C/005153
Active substance
tulathromycin
International non-proprietary name (INN) or common name
tulathromycin
Species
  • Cattle
  • Pigs
  • Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes
QJ01FA94
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
CEVA Santé Animale
Date of issue of marketing authorisation valid throughout the European Union
24/04/2020
Contact address

10 avenue de La Ballastière
33500 Libourne
France

Product information

24/04/2020 Tulaven - EMEA/V/C/005153 -

Contents

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Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Cattle: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis susceptible to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment.

Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis susceptible to tulathromycin.

Pigs: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica susceptible to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. The product should only be used if pigs are expected to develop the disease within 2–3 days.

Sheep: Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.

Assessment history

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