Aivlosin

Authorised

This medicine is authorised for use in the European Union

tylvalosin

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website

Aivlosin : EPAR - Medicine overview

Product information

Aivlosin : EPAR - Product Information

Aivlosin : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Aivlosin
• Active substance:
  tylvalosin
• International non-proprietary name (INN) or common name:
  tylvalosin

Pharmacotherapeutic group

• Antiinfectives for systemic use
• Antibacterials for systemic use
• Macrolides

Authorisation details

• EMA product number:
  EMEA/V/C/000083

Assessment history

Changes since initial authorisation of medicine

Aivlosin : EPAR - Procedural steps taken and scientific information after authorisation

Aivlosin-V-C-83-II-0078 : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Aivlosin (II-0078)

Adopted Reference Number: EMA/CVMP/238731/2020

Aivlosin-V-C-83-II-0064 : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Aivlosin

Adopted Reference Number: EMA/CVMP/231759/2016

Aivlosin-V-C-83-X-0051 : EPAR - Assessment Report - Extension

Adopted

CVMP post-authorisation summary of positive opinion for Aivlosin

Adopted Reference Number: EMA/CVMP/585227/2013

CVMP summary of opinion: Aivlosin 625 mg/g granules for use in drinking water for pheasants

Adopted Reference Number: EMEA/CVMP/627079/2009

CVMP summary of opinion for Aivlosin 625 mg/g granules for use in drinking water for pigs

Adopted Reference Number: EMEA/CVMP/106523/2009

CVMP summary of opinion: Aivlosin (previously: acetylisovaleryltylosin)

Adopted Reference Number: EMEA/CVMP/91929/2008

Initial marketing authorisation documents

Aivlosin : EPAR - Scientific Discussion

Aivlosin : EPAR - Procedural steps taken before authorisation