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Synflorix suspension for injection in pre-filled syringe

Last Updated on eMC 08-Apr-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 08-Apr-2014 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • 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: 20-Feb-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 & 5.1 - COMPASS end of study results

Updated on 07-Mar-2014 and displayed until 08-Apr-2014

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 21-Feb-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

1)  Update with data from the pooling of studies
10) Updated with new date of revision of text

Updated on 27-Feb-2014 and displayed until 07-Mar-2014

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • 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: 20-Feb-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 Updated with the COMPAS end of study results
Section 5.3 Updated with the COMPAS end of study results
Section 10 - commission decision approval date.

Updated on 30-Jan-2014 and displayed until 27-Feb-2014

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 27-Jan-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.8  safety update
10   Updated with new date of revision of text

Updated on 17-Dec-2013 and displayed until 30-Jan-2014

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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: 25-Nov-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.1,  4.4,  5.1
Extension of the indication to include active immunisation against pneumonia caused by Streptococcus Pneumonia

10  Updated with new date of revision of text

Updated on 27-Sep-2013 and displayed until 17-Dec-2013

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 19-Sep-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.5   Update with co-administration with Nimenrix in order to align the Prescribing Information of both medicinal products supported by results of study MenACWY-TT-080 BST 10PN-PD-DIT-029 and -031.

10   Updated with new date of revision of text

Updated on 12-Jul-2013 and displayed until 27-Sep-2013

Reasons for adding or updating:

  • 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: 28-Jun-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

5.1   Update with the additon of effectiveness data against invasive pneumococcal disease published real life effectiveness data.

10    Updated with new date of revision of text

Updated on 03-Jun-2013 and displayed until 12-Jul-2013

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 30-May-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.8  Updated with data from the pooling of studies

10  Updated with new date of revision of text

Updated on 26-Nov-2012 and displayed until 03-Jun-2013

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: 25-Oct-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.4 - Addition of syncope warning
10 - Updated with new date of revision of text

Updated on 26-Oct-2012 and displayed until 26-Nov-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: 08-Oct-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Removal of Black Triangle

10.  Revision date changed

Updated on 13-Feb-2012 and displayed until 26-Oct-2012

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 4.8 - Undesirable Effects
  • 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: 01-Feb-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

2.  Minor admin
4.2  Minor admin in line with QRD template
4.8  Updated with information on common adverse reactions HHE
5.1  Addition:The European Medicines Agency has deferred the obligation to submit the results of studies with Synflorix in one or more subsets of the paediatric population in diseases caused by Streptococcus pneumoniae and in acute otitis media caused by Haemophilus influenzae (see section 4.2 for information on paediatric use).

10  Revision date 

Updated on 19-Aug-2011 and displayed until 13-Feb-2012

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 08-Aug-2011

Legal Category:POM

Black Triangle (CHM): YES

Updated on 18-Aug-2011 and displayed until 19-Aug-2011

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • 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: 08-Aug-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

4.1 Increase in age from 2year up to 5 years
4.2 New schedule for 2 to 5 years old
4.4 Reference to 2 year old  changed to 5 years
4.8 Updated with information
5.1 Updated with new clinical trial data on older children
10  Updated with new date of revision of text

Updated on 11-Feb-2011 and displayed until 18-Aug-2011

Reasons for adding or updating:

  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 24-Jan-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

4.2 Considerable changes to include new schedule and pre-term infant data
4.4 Change in the ordering of the paragraphs
4.6 New section title to include fertility (although eMC not able to convert)
4.8 Inclusion of pre-term infant data
5.1 Considerable changes to inlcude new schedule and pre-term infant data
10. 24/01/2011

Updated on 28-Jan-2010 and displayed until 11-Feb-2011

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): YES

Company contact details

GlaxoSmithKline UK

Company image
Address

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Fax

+44 (0)208 990 4328

Telephone

+44 (0)800 221 441

Medical Information e-mail

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

Pneumococcal polysaccharide conjugate vaccine

Legal categories

POM - Prescription Only Medicine

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