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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 25/01/2012
SPC ACWY Vax Vaccine

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 25/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4  warning of syncope

10  revision date
Updated on 10/02/2011 and displayed until 25/01/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Removal of Black Triangle
Date of revision of text on the SPC:   09-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
1.  Removal of black triangle
10. Revision date 9 Feb 2011
Updated on 24/05/2010 and displayed until 10/02/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   31-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 2 - Addition of "polysaccharide"
Updated on 21/08/2008 and displayed until 24/05/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   23-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


1. New name & description & BLACK TRIANGLE

2. More information on name Neisseria meningitidis and that a full list of excipients is available in section 6.1

3. More information

4.1 Age of population from >2 years and a 'catch all' statement "..should be used in accordance with available official recommendations."

4.2 Removes information on those previously immunised with serogroup C. remove negative statement on response to infants. Adds statement about revaccination if subject is at risk

4.3 Similar wording

4.4 Similar except the reference to immunising children.

4.5 New information

4.6 Both state lack of data, but new SmPC "may be considered when there is an increase risk for meningococcal disease. Plus lactation information

4.7 Same

4.8 New SmPC is very comprehensive , new tabular system and includes frequencies of adverse events

4.9 New SmPC provides details of the number of cases

5.1 A lot more information including details on Late Complement Component Deficiency

5.2 Similar

5.3 Preclinical data reveal no special hazard for humans based on general safety tests performed in animals

6.1 New powder ingredients: Sucrose & trometamol ( previously Lactose only)

6.2 No data therefore do not mix

6.3 3 years plus information on in-use stability of 8 hours (previously only 2 years)

6.4 Additional information on 'Do not freeze' & 'Store in the original package in order to protect from light'

6.5 Less detailed

6.6 Similar except the use within 1 hour has been deleted

7 similar

8 New PL number PL 10592/0301

9 New date 23/06/2008

10 New date 23/06/2008
Updated on 14/12/2005 and displayed until 21/08/2008
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 23/07/2003 and displayed until 14/12/2005
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 10/03/2003 and displayed until 23/07/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 12/09/2002 and displayed until 10/03/2003
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 29/07/2002 and displayed until 12/09/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 10/08/2001 and displayed until 29/07/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 18/01/2001 and displayed until 10/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 12/01/2001 and displayed until 18/01/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  acwy meningococcal polysaccharide