Celvapan

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

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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 and fatigue (tiredness). For the full list of all side effects reported with Celvapan, see the package leaflet.

Celvapan 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 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.

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

A risk management plan has been developed to ensure that Celvapan 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 Celvapan, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Celvapan

The European Commission granted a marketing authorisation valid throughout the European Union for Celvapan on 4 March 2009.

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

Name Language First published Last updated
Celvapan : EPAR - Summary for the public BG = bălgarski 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public ES = español 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public CS = čeština 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public DA = dansk 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public DE = Deutsch 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public ET = eesti keel 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public EL = elliniká 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public EN = English 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public FR = français 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public IT = italiano 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public LV = latviešu valoda 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public LT = lietuvių kalba 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public HU = magyar 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public MT = Malti 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public NL = Nederlands 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public PL = polski 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public PT = português 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public RO = română 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public SK = slovenčina 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public SL = slovenščina 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public FI = suomi 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public SV = svenska 2009-10-08 2015-06-25
Celvapan : EPAR - Summary for the public HR = Hrvatski 2009-10-08 2015-06-25

This EPAR was last updated on 27/01/2016 .

Authorisation details

Product details

Product details for Celvapan
NameCelvapan
Agency product numberEMEA/H/C/000982
Active substance

whole virion, inactivated containing antigen: A/California/07/2009 (H1N1)v

International non-proprietary name (INN) or common name

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

Therapeutic area Influenza, HumanDisease OutbreaksImmunization
Anatomical therapeutic chemical (ATC) code J07BB01

Publication details

Publication details for Celvapan
Marketing-authorisation holder

Nanotherapeutics Bohumil, s.r.o.

Revision11
Date of issue of marketing authorisation valid throughout the European Union04/03/2009

Contact address:

Nanotherapeutics Bohumil, s.r.o.
Bohumill38 
28163 Jevany
Czech Republic

Product information

Product information

30/11/2015  Celvapan -EMEA/H/C/000982 -T/0031

Name Language First published Last updated
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-01-27

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
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08  

Pharmacotherapeutic group

Vaccines

Therapeutic indication

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

Celvapan should be used in accordance with official guidance.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Celvapan : EPAR - Public assessment report HR = Hrvatski 2009-04-08  
Committee for medicinal products for human use summary of positive opinion for Celvapan HR = Hrvatski 2008-12-17  

Authorised

This medicine is approved for use in the European Union

More information on Celvapan