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ACWY Vax Vaccine

Last Updated on eMC 14-Mar-2014 View document  | GlaxoSmithKline UK Contact details

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 14-Mar-2014 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 24-Feb-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Sec 4.4 – addition of re-vaccination

Sec 4.8 – addition of reporting of adverse reaction details

Sec 5.1 – addition of 4 year persistence data

Updated on 21-Oct-2013 and displayed until 14-Mar-2014

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 08-Oct-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

7  Update to MAH name
10 Updated with new date of revision of text

Updated on 29-Aug-2012 and displayed until 21-Oct-2013

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 10-Aug-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

2.  Rewording of excipient statement.  Inclusion of wording regarding sodium content.
4.2 Inclusion of section regarding paediatric population.  Inclusion of wording regarding reconstitution
4.4 Inclusion of wording regarding sodium content
4.6 Update and rewording in line with QRD
4.7 Rewording of existing text
4.8 change to the order of some AEs
5.3 Rewording of existing text
6.4 Rewording of existing text
6.6 Update and rewording in line with QRD (disposal wording)
9 Update with new renewal date
10 Updated with new date of revision of text

Updated on 25-Jan-2012 and displayed until 29-Aug-2012

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-Feb-2011 and displayed until 25-Jan-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-May-2010 and displayed until 10-Feb-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-Aug-2008 and displayed until 24-May-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-Dec-2005 and displayed until 21-Aug-2008

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation

Updated on 23-Jul-2003 and displayed until 14-Dec-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-Mar-2003 and displayed until 23-Jul-2003

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Updated on 12-Sep-2002 and displayed until 10-Mar-2003

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Updated on 29-Jul-2002 and displayed until 12-Sep-2002

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Updated on 10-Aug-2001 and displayed until 29-Jul-2002

Reasons for adding or updating:

  • Transferred from eMC version 1

Updated on 18-Jan-2001 and displayed until 10-Aug-2001

Reasons for adding or updating:

  • No reasons supplied

Updated on 12-Jan-2001 and displayed until 18-Jan-2001

Reasons for adding or updating:

  • No reasons supplied

Company contact details

GlaxoSmithKline UK

Company image
Address

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Fax

+44 (0)208 990 4328

Medical Information e-mail
Telephone

0800 221 441

E-mail
Customer Care direct line

0800 221 441

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?

Active ingredients

acwy meningococcal polysaccharide

Legal categories

POM - Prescription Only Medicine

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