Prepandrix

prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Prepandrix has been withdrawn at the request of the marketing-authorisation holder.

List item

Prepandrix : EPAR - Summary for the public (PDF/655.18 KB)

First published: 17/08/2009
Last updated: 21/05/2013
- Bulgarian
  (PDF/776.12 KB)
- Czech
  (PDF/735.51 KB)
- Dutch
  (PDF/677.38 KB)
- Estonian
  (PDF/653.25 KB)
- Finnish
  (PDF/655.55 KB)
- French
  (PDF/682.1 KB)
- German
  (PDF/680.17 KB)
- Greek
  (PDF/782.77 KB)
- Hungarian
  (PDF/753.62 KB)
- Italian
  (PDF/654.6 KB)
- Latvian
  (PDF/750.57 KB)
- Lithuanian
  (PDF/705.98 KB)
- Maltese
  (PDF/759.76 KB)
- Polish
  (PDF/753.77 KB)
- Portuguese
  (PDF/655.51 KB)
- Romanian
  (PDF/705.46 KB)
- Slovak
  (PDF/760.78 KB)
- Slovenian
  (PDF/744.7 KB)
- Spanish
  (PDF/655.14 KB)
- Swedish
  (PDF/677.15 KB)

More detail is available in the summary of product characteristics

This EPAR was last updated on 23/02/2021

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)	Influenza, Human Immunization Disease Outbreaks
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

List item

Prepandrix : EPAR - Product Information (PDF/1.01 MB)

First published: 21/12/2009
Last updated: 26/07/2019
- Bulgarian
  (PDF/2.84 MB)
- Croatian
  (PDF/1.87 MB)
- Czech
  (PDF/2.53 MB)
- Danish
  (PDF/1.85 MB)
- Dutch
  (PDF/1.82 MB)
- Estonian
  (PDF/1.79 MB)
- Finnish
  (PDF/1.85 MB)
- French
  (PDF/1.85 MB)
- German
  (PDF/1.85 MB)
- Greek
  (PDF/2.91 MB)
- Hungarian
  (PDF/2.51 MB)
- Icelandic
  (PDF/1.82 MB)
- Italian
  (PDF/1.84 MB)
- Latvian
  (PDF/2.6 MB)
- Lithuanian
  (PDF/1.94 MB)
- Maltese
  (PDF/2.61 MB)
- Norwegian
  (PDF/1.8 MB)
- Polish
  (PDF/2.56 MB)
- Portuguese
  (PDF/1.85 MB)
- Romanian
  (PDF/1.97 MB)
- Slovak
  (PDF/2.56 MB)
- Slovenian
  (PDF/2.48 MB)
- Spanish
  (PDF/1.81 MB)
- Swedish
  (PDF/1.81 MB)

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

List item

Prepandrix : EPAR - All Authorised presentations (PDF/599.2 KB)

First published: 17/08/2009
Last updated: 17/08/2009
- Bulgarian
  (PDF/706.57 KB)
- Croatian
  (PDF/731.49 KB)
- Czech
  (PDF/688.89 KB)
- Danish
  (PDF/636.44 KB)
- Dutch
  (PDF/598.72 KB)
- Estonian
  (PDF/599.16 KB)
- Finnish
  (PDF/594.07 KB)
- French
  (PDF/635.45 KB)
- German
  (PDF/599.05 KB)
- Greek
  (PDF/692.08 KB)
- Hungarian
  (PDF/685.93 KB)
- Icelandic
  (PDF/683.46 KB)
- Italian
  (PDF/633.94 KB)
- Latvian
  (PDF/688.77 KB)
- Lithuanian
  (PDF/667.71 KB)
- Maltese
  (PDF/691.47 KB)
- Norwegian
  (PDF/682.3 KB)
- Polish
  (PDF/687.41 KB)
- Portuguese
  (PDF/635.96 KB)
- Romanian
  (PDF/671.36 KB)
- Slovak
  (PDF/686.86 KB)
- Slovenian
  (PDF/614.22 KB)
- Spanish
  (PDF/599.09 KB)
- Swedish
  (PDF/599.04 KB)

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.

Assessment history

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

How useful was this page?

Add your rating

★ ★ ★ ★ ★

Prepandrix

Table of contents

Overview

Prepandrix : EPAR - Summary for the public (PDF/655.18 KB)

Authorisation details

Product information

Prepandrix : EPAR - Product Information (PDF/1.01 MB)

Contents

Prepandrix : EPAR - All Authorised presentations (PDF/599.2 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Prepandrix : EPAR - Procedural steps taken and scientific information after authorisation (PDF/1019.77 KB)

Prepandrix-H-C-822-P46-0054 : EPAR - Assessment Report (PDF/1.83 MB)

Prepandrix-H-C-822-P46-0055 : EPAR - Assessment Report (PDF/997.23 KB)

Prepandrix-H-C-822-PSUV-0049 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/636.26 KB)

Prepandrix-H-C-822-II-0029 : EPAR - Assessment Report - Variation (PDF/1.09 MB)

Prepandrix-H-C-822-II-0026 : EPAR - Assessment Report - Variation (PDF/1.31 MB)

Prepandrix-H-C-822-II-0005 : EPAR - Assessment Report - Variation (PDF/1.01 MB)

CHMP post-authorisation summary of positive opinion for Prepandrix (PDF/32.48 KB)

Initial marketing-authorisation documents

CHMP summary of positive opinion for Prepandrix (PDF/766.62 KB)

Prepandrix : EPAR - Public assessment report (PDF/969.71 KB)

More information on Prepandrix

Public statement on Prepandrix: Withdrawal of the marketing authorisation in the European Union (PDF/123.41 KB)

Related content

How useful was this page?