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The marketing authorisation for Prepandrix has been withdrawn at the request of the marketing-authorisation holder.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 | |
Product information
20/09/2018 Prepandrix - EMEA/H/C/000822 - IB/0077
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
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.