Zactran

Authorised

This medicine is authorised for use in the European Union

gamithromycin

Overview

Introduction

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

Zactran : EPAR - Summary for the public

Product information

Zactran : EPAR - Product information

Zactran : EPAR - All Authorised presentations

Product details

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

Pharmacotherapeutic group

Antibacterials for systemic use

Authorisation details

• EMA product number:
  EMEA/V/C/000129

Assessment history

Changes since initial authorisation of medicine

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

Zactran-V-C-129-II-0036 : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for ZactranIII

Adopted Reference Number: EMA/CVMP/763148/2017

Zactran-V-C-129-X-0034 : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Zactran (X/0034)

Adopted Reference Number: EMA/CVMP/129619/2017

Zactran-V-C-129-X-0027 : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Zactran

Adopted Reference Number: EMA/CVMP/749682/2015

Initial marketing authorisation documents

Zactran : EPAR - Scientific Discussion

Zactran : EPAR - Procedural steps taken before authorisation

Committee for medicinal products for veterinary use summary of opinion: Zactran: International Non-proprietary Names (INN): Gamithromycin

Adopted Reference Number: EMEA/CVMP/220772/2008