Aivlosin

tylvalosin

Table of contents

Opinion

On 20 May 2020, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Aivlosin. The marketing authorisation holder for this veterinary medicinal product is ECO Animal Health Europe Limited.

Aivlosin granules for use in drinking water are currently authorised for use in pigs for the “Treatment and metaphylaxis of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis”. This variation is to add a new indication to this formulation for “Treatment and metaphylaxis of swine enzootic pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae”. As a consequence, changes to the dosage have been made, and the withdrawal period has been increased to 2 days, these changes will also apply to the already authorised indication for Aivlosin granules for use in drinking water for pigs.

Detailed conditions for the use of this product are described in the updated summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the revised European public assessment report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.


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
Aivlosin
Agency product number
EMEA/V/C/000083
International non-proprietary name (INN) or common name
  • tylvalosin
Species
Pheasants
Chicken
Turkeys
Pigs
Active substance
  • tylvalosin
Date opinion adopted
20/05/2020
Company name
ECO Animal Health Europe Limited
Status
Positive
Application type
Post-authorisation

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