Prepandrix

RSS

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

Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Prepandrix has been withdrawn at the request of the marketing-authorisation holder. 

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 assessmentAccelerated 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

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Product information documents contain:

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.

Assessment history

Changes since initial authorisation of medicine

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