Zostavax

zoster vaccine (live)

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This is a summary of the European public assessment report (EPAR) for Zostavax. 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 Zostavax.

What is Zostavax?

Zostavax is a vaccine that is available as a powder and solvent to be made up into a solution for injection. The active substance is the attenuated (weakened) varicella-zoster virus.

What is Zostavax used for?

Zostavax is used to vaccinate people aged 50 years or older, to prevent herpes zoster (also known as zoster or shingles) and the long-lasting nerve pain that may follow the disease (post-herpetic neuralgia).

The vaccine can only be obtained with a prescription.

How is Zostavax used?

Zostavax is given as a single dose injected under the skin, preferably around the shoulder.

How does Zostavax work?

Herpes zoster, or shingles, is a disease caused by the varicella-zoster virus, the same virus that causes chickenpox. Shingles develops in people who have had chickenpox earlier in life, generally as a child. After chickenpox, the varicella-zoster virus stays in the body, in the nervous system, in a ‘dormant’ (inactive) state. Sometimes, after many years, and for reasons which are not fully understood, the virus becomes active again, and the patient develops shingles, a painful, blistering rash typically in one part of the body. The rash takes usually several weeks to clear, and may be followed by severe long-lasting pain (post-herpetic neuralgia) in the area where the rash was.

The risk of developing shingles seems to be linked to a decline in the specific immunity (protection) against varicella-zoster virus. Zostavax is a vaccine that was shown to ‘boost’ this specific immunity, protecting against shingles and the pain associated with it.

How has Zostavax been studied?

The main study of Zostavax compared the vaccine with placebo (a dummy vaccine) in around 39,000 patients aged between 59 and 99 years. The study was a double-blind trial, which means that neither the doctor nor the patient knew what treatment the patient was receiving. The patients were followed for 2 to 4.5 years after vaccination. The main measure of effectiveness was based on the number of people who developed shingles and post-herpetic pain.

Two further studies looked at Zostavax in over 1,000 patients aged 50 years or older, of whom 389 were between 50 and 59 years of age. The studies looked at the ability of the vaccine to stimulate the production of antibodies against varicella-zoster virus in the blood, four weeks after injection.

What benefit has Zostavax shown during the studies?

Zostavax was more effective than placebo in preventing shingles. Fewer people developed shingles after vaccination with Zostavax than placebo: 315 of the 19,254 patients who received Zostavax had shingles during the study, compared with 642 of the 19,247 who received placebo. Zostavax was also more effective than placebo in preventing post-herpetic neuralgia: 27 of the Zostavax patients had post-herpetic neuralgia, compared with 80 in the placebo group.

The additional two studies showed that patients vaccinated with Zostavax had blood levels of antibodies against varicella-zoster virus that were about two to three times higher four weeks after vaccination. The effect was seen both in patients aged between 50 and 59 years and in those aged 60 years and older.

What is the risk associated with Zostavax?

In studies, the most common side effects with Zostavax (seen in more than 1 patient in 10) are reactions at the site of the injection (redness, pain, swelling, itching, warmth and bruising). For the full list of all side effects reported with Zostavax, see the package leaflet.

Zostavax should not be used in people who may be hypersensitive (allergic) to any of the ingredients of the vaccine, including neomycin (an antibiotic). The vaccine must not be used in people who have problems with their immune system, either because they have a disease such as leukaemia, lymphoma or acquired immune deficiency syndrome (AIDS), or because they are taking medicines that affect the immune system. It must also not be used in patients with active untreated tuberculosis or in pregnant women. For the full list of restrictions, see the package leaflet.

Why has Zostavax been approved?

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

Other information about Zostavax

The European Commission granted a marketing authorisation valid throughout the European Union for Zostavax to Sanofi Pasteur MSD SNC on 19 May 2006. After five years, the marketing authorisation was renewed for a further five years.

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

Name Language First published Last updated
Zostavax : EPAR - Summary for the public BG = bălgarski 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public ES = español 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public CS = čeština 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public DA = dansk 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public DE = Deutsch 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public ET = eesti keel 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public EL = elliniká 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public EN = English 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public FR = français 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public IT = italiano 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public LV = latviešu valoda 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public LT = lietuvių kalba 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public HU = magyar 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public MT = Malti 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public NL = Nederlands 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public PL = polski 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public PT = português 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public RO = română 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public SK = slovenčina 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public SL = slovenščina 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public FI = suomi 17/01/2007 31/03/2011
Zostavax : EPAR - Summary for the public SV = svenska 17/01/2007 31/03/2011

This EPAR was last updated on 04/07/2014 .

Authorisation details

Product details

Product details for Zostavax
NameZostavax
Agency product numberEMEA/H/C/000674
Active substance

varicella-zoster virus (live, attenuated)

International non-proprietary name (INN) or common name

zoster vaccine (live)

Therapeutic area ImmunizationHerpes Zoster
Anatomical therapeutic chemical (ATC) code J07BK02

Publication details

Publication details for Zostavax
Marketing-authorisation holder

Sanofi Pasteur MSD, SNC

Revision17
Date of issue of marketing authorisation valid throughout the European Union19/05/2006

Contact address:

Sanofi Pasteur MSD, SNC
162 avenue Jean Jaurès 
69007 Lyon 
France

Product information

Product information

06/05/2014  Zostavax -EMEA/H/C/000674 -IG/0435

Name Language First published Last updated
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014
Zostavax : EPAR - Product Information SV = svenska 14/12/2009 04/07/2014

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
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  
Zostavax : EPAR - All Authorised presentations SV = svenska 17/01/2007  

Pharmacotherapeutic group

Viral Vaccine

Therapeutic indication

Zostavax is indicated for prevention of herpes zoster ('zoster' or shingles) and herpes-zoster-related post-herpetic neuralgia.

Zostavax is indicated for immunisation of individuals 50 years of age or older.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Zostavax : EPAR - Procedural steps taken before authorisation SV = svenska 17/01/2007  
Zostavax : EPAR - Scientific Discussion SV = svenska 17/01/2007  

Authorised

This medicine is approved for use in the European Union

More information on Zostavax