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 22/01/2019

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 monitoringAdditional 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
Ology Bioservices Ireland LTD
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
17/02/2012
Contact address

Wilton Park House
Wilton Place
Dublin 2
D02P447
Ireland

Product information

11/01/2019 Vepacel - EMEA/H/C/002089 - T/0019

Contents

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Pharmacotherapeutic group

Influenza vaccines

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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