Naxcel

Authorised

This medicine is authorised for use in the European Union

ceftiofur

Overview

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

Naxcel : EPAR - Summary for the public

Product information

Naxcel : EPAR - Product Information

Naxcel : EPAR - All Authorised presentations

Product details

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

Pharmacotherapeutic group

Antibacterials for systemic use

Authorisation details

• EMA product number:
  EMEA/V/C/000079

Assessment history

Changes since initial authorisation of medicine

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

Naxcel-V-C-79-II-13 : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of negative opinion for Naxcel

Adopted Reference Number: EMA/CVMP/283906/2012

Naxcel-V-C-79-II-12 : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Naxcel

Adopted Reference Number: EMA/CVMP/62249/2011

Committee for medicinal products for veterinary use summary of opinion: Naxcel: International Non-proprietary Name (INN): Ceftiofur

Adopted Reference Number: EMEA/CVMP/405655/2009

Initial marketing authorisation documents

Naxcel : EPAR - Scientific Discussion

Naxcel : EPAR - Procedural steps taken before authorisation