Prepandrix
prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Table of contents
Overview
The marketing authorisation for Prepandrix has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Prepandrix
|
| Agency product number |
EMEA/H/C/000822
|
| Active substance |
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
|
| International non-proprietary name (INN) or common name |
prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J07BB02
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
GlaxoSmithKline Biologicals S.A.
|
| Revision |
13
|
| Date of issue of marketing authorisation valid throughout the European Union |
14/05/2008
|
| Contact address |
Rue de l'Institut, 89
B-1330 Rixensart Belgium |
Product information
20/09/2018 Prepandrix - EMEA/H/C/000822 - IB/0077
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
Vaccines
Therapeutic indication
Active immunisation against H5N1 subtype of influenza-A virus.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains.
Prepandrix should be used in accordance with official guidance.