Pandemrix

influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (x-179a)

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This is a summary of the European public assessment report (EPAR) for Pandemrix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pandemrix.

What is Pandemrix?

Pandemrix is a vaccine that is given by injection. It contains parts of influenza (flu) viruses that have been inactivated. Pandemrix contains a flu strain called A/California/7/2009 (H1N1)v-like strain (X‑179A).

What is Pandemrix used for?

Pandemrix is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus. It should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccine is not available and if immunisation against (H1N1)v is considered necessary. Pandemrix is given according to official recommendations.

The vaccine can only be obtained with a prescription.

How is Pandemrix used?

Pandemrix is given as one dose, injected into the muscle of the shoulder or thigh. A second dose may be given after an interval of at least three weeks. From 10 years of age the dose is 0.5 ml; younger children aged from six months to nine years receive 0.25 ml per dose.

How does Pandemrix work?

Pandemrix is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Pandemrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v 2009. The virus has first been inactivated (killed) so that it does not cause any disease.

When a person is given the vaccine, the immune system recognises the virus as ‘foreign’ and makes antibodies against it. The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. This will help to protect against the disease caused by the virus.

Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with a solvent. The resulting ‘emulsion’ is then injected. The solvent contains an ‘adjuvant’ (a compound containing oil) to enhance the immune response.

How has Pandemrix been studied?

Pandemrix was originally developed as a pandemic vaccine, and was used during the influenza A (H1N1) pandemic declared in June 2009. Six main studies have been carried out that looked at the ability of a two-dose schedule of the vaccine to trigger an immune response in the following groups (the numbers given are for those who received Pandemrix in the studies):

  • healthy adults aged between 18 and 60 years (180 subjects in two studies);
  • healthy elderly subjects over the age of 60 years (120 subjects in one study);
  • healthy children (210 aged between three and 17 years, and 50 aged between six and 35 months, in three studies).

The studies in children also allowed the effectiveness of Pandemrix as a 0.5 ml dose to be compared with that of a 0.25 ml dose.

What benefit has Pandemrix shown during the studies?

In all of the studies, the vaccine was shown to bring about protective levels of antibodies to a satisfactory level, in line with the criteria laid down by the CHMP.

The CHMP noted that a single dose was able to trigger immunity to a satisfactory level in adults (including the elderly), adolescents and children from 10 years of age. In children aged between six months and nine years, 0.25 ml doses were as effective as 0.5 ml doses.

What is the risk associated with Pandemrix?

The most common side effects with Pandemrix in adults (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), swelling and pain at the site of the injection, shivering, increased sweating and fatigue (tiredness). Side effects are similar in children. For the full list of all side effects reported with Pandemrix, see the package leaflet.

Pandemrix must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate. Vaccination should be postponed in subjects with severe fever or an acute (short-lived) infection.

Why has Pandemrix been approved?

The CHMP decided that Pandemrix’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Pandemrix was originally authorised under ‘exceptional circumstances’, because, for scientific reasons, limited information was available at the time of approval. As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 12 August 2010.

Following rare cases of narcolepsy (a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly) among people given the vaccine, it was concluded that Pandemrix should only be used if the recommended seasonal influenza vaccine is not available and if immunisation against H1N1 is still needed.

What measures are being taken to ensure the safe and effective use of Pandemrix?

A risk management plan has been developed to ensure that Pandemrix is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pandemrix, including the appropriate precautions to be followed by healthcare professionals and patients.

Additionally, the company that markets Pandemrix has to submit the results of non-clinical and clinical studies to clarify the relationship between vaccination with Pandemrix and narcolepsy.

Other information about Pandemrix

The European Commission granted a marketing authorisation valid throughout the European Union for Pandemrix on 20 May 2008.

For more information about treatment with Pandemrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Pandemrix : EPAR - Summary for the public BG = bălgarski 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public ES = español 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public CS = čeština 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public DA = dansk 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public DE = Deutsch 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public ET = eesti keel 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public EL = elliniká 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public EN = English 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public FR = français 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public IT = italiano 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public LV = latviešu valoda 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public LT = lietuvių kalba 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public HU = magyar 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public MT = Malti 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public NL = Nederlands 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public PL = polski 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public PT = português 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public RO = română 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public SK = slovenčina 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public SL = slovenščina 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public FI = suomi 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public SV = svenska 22/12/2009 10/03/2015
Pandemrix : EPAR - Summary for the public HR = Hrvatski 22/12/2009 10/03/2015

This EPAR was last updated on 17/03/2015 .

Authorisation details

Product details

Product details for Pandemrix
NamePandemrix
Agency product numberEMEA/H/C/000832
Active substance

split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A

International non-proprietary name (INN) or common name

influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (x-179a)

Therapeutic area Influenza, HumanDisease OutbreaksImmunization
Anatomical therapeutic chemical (ATC) code J07BB02
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Pandemrix
Marketing-authorisation holder

GlaxoSmithKline Biologicals S.A.

Revision19
Date of issue of marketing authorisation valid throughout the European Union20/05/2008

Contact address:

GlaxoSmithKline Biologicals S.A.
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

Product information

18/12/2014  Pandemrix -EMEA/H/C/000832 -P46/0103

Name Language First published Last updated
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 10/03/2015

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

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.


Name Language First published Last updated
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009  

Pharmacotherapeutic group

Influenza vaccines

Therapeutic indication

Prophylaxis of influenza caused by A (H1N1)v 2009 virus. In persons under 20 years of age, Pandemrix should only be used if the recommended annual seasonal trivalent influenza vaccine is not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).

Pandemrix should be used in accordance with official guidance.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Pandemrix-H-C-832-P46-0102/0103 : EPAR - Assessment Report HR = Hrvatski 17/03/2015  
Pandemrix-H-C-832-P46-0099 : EPAR - Assessment Report HR = Hrvatski 17/03/2015  
Pandemrix : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 04/12/2009 10/03/2015
Pandemrix-H-C-832-II-0069 : EPAR - Assessment Report - Variation HR = Hrvatski 08/10/2014  
Pandemrix-H-C-832-II-0061 : EPAR - Assessment Report - Variation HR = Hrvatski 09/12/2013  
Pandemrix-H-C-832-II-0052 : EPAR - Assessment Report - Variation HR = Hrvatski 25/11/2011  
Pandemrix-H-C-832-A20-0045 : EPAR - Assessment Report - Article 20 HR = Hrvatski 25/11/2011  
Pandemrix-H-C-000832-II-0051 : EPAR - Assessment Report - Variation HR = Hrvatski 25/11/2011  
Pandemrix-H-C-000832-II-0046 : EPAR - Assessment Report - Variation HR = Hrvatski 25/07/2011  
Pandemrix-H-C-000832-II-0048: EPAR - Assessment Report - Variation HR = Hrvatski 25/07/2011  
Pandemrix-H-C-832-SW-0041 : EPAR - Assessment Report - Variation HR = Hrvatski 04/10/2010  
Pandemrix-H-C-832-II-0033 : EPAR - Assessment Report - Variation HR = Hrvatski 04/03/2010  
Pandemrix-H-C-832-II-0034 : EPAR - Assessment Report - Variation HR = Hrvatski 23/12/2009  
Pandemrix-H-C-832-II-0028 : EPAR - Assessment Report - Variation HR = Hrvatski 23/12/2009  
Pandemrix-H-C-832-II-0032 : EPAR - Assessment Report - Variation HR = Hrvatski 23/12/2009  
Pandemrix-H-C-832-II-0026 : EPAR - Assessment Report - Variation HR = Hrvatski 04/12/2009  
Pandemrix-H-C-832-II-0025 : EPAR - Assessment Report - Variation HR = Hrvatski 04/12/2009  
Pandemrix-H-C-832-II-0024 : EPAR - Assessment Report - Variation HR = Hrvatski 04/12/2009  
Pandemrix-H-C-832-II-0023 : EPAR - Assessment Report - Variation HR = Hrvatski 04/12/2009  
Pandemrix-H-C-832-II-0019 : EPAR - Assessment Report - Variation HR = Hrvatski 16/11/2009  
Pandemrix-H-C-832-PU-0017 : EPAR - Assessment Report - Variation HR = Hrvatski 02/10/2009  
Pandemrix-H-C-832-II-0005 : EPAR - Assessment Report - Variation HR = Hrvatski 14/08/2009  

Initial marketing-authorisation documents

Name Language First published Last updated
Pandemrix : EPAR - Public assessment report HR = Hrvatski 03/06/2008  
Committee for medicinal products for human use, summary of positive opinion for Pandemrix HR = Hrvatski 21/02/2008