Vepacel

RSS

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

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Vepacel has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 28/10/2020

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
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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