Vepacel
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)
Table of contents
Overview
The marketing authorisation for Vepacel has been withdrawn at the request of the marketing authorisation holder.
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 |
2 Shelbourne Buildings |
Product information
11/01/2019 Vepacel - EMEA/H/C/002089 - T/0019
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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.