Vepacel
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Vepacel has been withdrawn at the request of the marketing authorisation holder.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) |
|
| 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 | |
Product information
11/01/2019 Vepacel - EMEA/H/C/002089 - T/0019
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Influenza vaccines
Therapeutic indication
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.