Celvapan

influenza vaccine (H1N1)v (whole virion, inactivated, prepared in cell culture)

This is a summary of the European Public Assessment Report (EPAR) for Celvapan. 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 Celvapan.

What is Celvapan?

Celvapan is a vaccine that is given by injection. It contains influenza (flu) viruses that have been inactivated (killed). Celvapan contains a flu strain called A/California/07/2009 (H1N1)v.

What is Celvapan used for?

Celvapan is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus. Celvapan is given according to official recommendations.

The medicine can only be obtained with a prescription.

How is Celvapan used?

Celvapan is given by injection into the muscle of the shoulder or thigh, as two doses at least three weeks apart.

How does Celvapan work?

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

When a person is given the vaccine, the immune system recognises the inactivated 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 helps to protect against the disease.

The viruses used in Celvapan are grown in mammal cells (‘vero cells’), as opposed to hen’s eggs.

How has Celvapan been studied?

Celvapan was originally developed as a pandemic vaccine, to be used during the influenza A (H1N1) pandemic declared in June 2009. Two main studies have been carried out that looked at the ability of two doses of Celvapan H1N1 given three weeks apart to trigger an immune response. One study involved 408 healthy adults, half of whom were over 60 years of age (202 received a full dose of Celvapan, the others a half dose) and the second involved 167 healthy children aged between six months and 17 years (101 received a full dose of Celvapan, the others a half dose).

What benefit has Celvapan shown during the studies?

In both studies, the full dose of 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.

What is the risk associated with Celvapan?

The most common side effects with Celvapan (seen in more than 1 people vaccinated in 10) are headache, pain at the site of the injection and fatigue (tiredness). For the full list of all side effects reported with Celvapan, see the Package Leaflet.

Celvapan should 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 formaldehyde, benzonase or sucrose.

Why has Celvapan been approved?

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

Celvapan 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.

Other information about Celvapan

The European Commission granted a marketing authorisation valid throughout the European Union for Celvapan to Baxter AG on 4 March 2009. The marketing authorisation is valid for five years, after which it can be renewed.

This EPAR was last updated on 28/07/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

22/06/2011  Celvapan -EMEA/H/C/000982 -IB/0018

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.

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza caused by A(H1N1)v 2009 virus.

Celvapan should be used in accordance with Official Guidance.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents