Vepacel

RSS

Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Vepacel. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vepacel.

This EPAR was last updated on 15/05/2017

Authorisation details

Product details
Name
Vepacel
Agency product number
EMEA/H/C/002089
Active substance
Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1)
International non-proprietary name (INN) or common name
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB01
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Nanotherapeutics UK LTD
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
16/02/2012
Contact address
10 Chiswell Street
London EC1Y 4UQ
United Kingdom

Product information

10/03/2017 Vepacel - EMEA/H/C/002089 - T/0017

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Anti infectives for systemic use

Therapeutic indication

Active immunisation against H5N1 subtype of influenza A virus.

This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains.

Vepacel should be used in accordance with Official guidance.

Assessment history

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