Tulissin

tulathromycin

Table of contents

Opinion

On 20 February 2020, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product Tulissin 100 mg/ml and 25 mg/ml solution for injection for cattle, pigs and sheep. The applicant for this veterinary medicinal product is Virbac S.A.

Tulissin is a medicinal product containing tulathromycin, an antibacterial for systemic use (macrolide) (ATCvet code QJ01FA94) as active substance. Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA. They act by stimulating the dissociation of peptidyl-tRNA from the ribosome during the translocation process.

Tulissin is a generic of Draxxin, which has been authorised in the EU since 11 November 2003. Studies have demonstrated the satisfactory quality of Tulissin and its bioequivalence to the reference product Draxxin. 

The full indication is:

Cattle (100 mg/ml)

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 (100 mg/ml and 25 mg/ml)

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 (100 mg/ml)

Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent

Dichelobacter nodosus requiring systemic treatment.

Detailed conditions for the use of this product will be described in the summary of product characteristics (SPC) which will be published in the European public assessment report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Tulissin and therefore recommends the granting of the marketing authorisation.


1 Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.       

Key facts

Name
Tulissin
Agency product number
EMEA/V/C/005073
International non-proprietary name (INN) or common name
  • tulathromycin
Species
Cattle
Pigs
Sheep
Active substance
  • tulathromycin
Generic

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.

Date opinion adopted
20/02/2020
Company name
Virbac S.A.
Status
Positive
Application type
Initial authorisation

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