Last Updated on eMC 20-10-2017 View medicine  | 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.

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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:12-10-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Changes to SPC:
- Section 4.2 - Addition of splenic dysfunction under 'special populations'. Clarity of wording that 3 dose schedule should be given as primary vaccination in infants starting vaccination before 6 month of age
- Section 4.4 - Addition of children with splenic dysfunction
Section 4.8 Update to MHRA adverse event reporting details
- Section 5.1 - Addition of children with splenic dysfunction to 'immunogenicity in special population'

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:22-06-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Reporting details for adverse effects omitted in previous upload of document.

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:22-06-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SPC:
- Section 1 - Inclusion of 4 dose vial
- Section 5.1 -  inclusion of immunogenicity information or Synflorix containing preservative 2-phenoxyethanol (2-PE)
- Section 6.1 -  Update to excipients list for 4 dose vial
- Section 6.3 - Inclusion of shelf life for 4 dose vial and administrative changes to existing text
- Section 6.5 - Administrative updates to text and inclusion of container contents for the 4 dose vial
Section 8 - Inclusion of MA numbers for 4 dose vials

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 4.8 - 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:27-01-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.2      Posology and method of administration

 

“9 months onwards” added to both paragraphs

 

“Special populations” added

4.4      Special warnings and precautions for use

 

Safety and immunogenicity data information added

4.8      Undesirable effects

 

“Special populations” added

5.1 Pharmacodynamic properties

2.4 Impact on nasopharyngeal carriage (NPC)

 

Clinical study information added

4.2 Additional immunogenicity data

 

Clinical study information added

4.4. Immunogenicity in special population

 

“Special populations” added

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:02-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 - we included 3 different names i.e. the tradename followed by the pharmaceutical form and the container for the pre-filled syringe and the multidose vial. This is also mentioned as such in the 3 separate Patient Leaflets.

Section 6.3 - the change in shelf-life from 3 to 4 years for the 1-dose and 2-dose vials.

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Date of revision of text on the SPC:10-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



-          Section 1: in the combined SmPC, ‘pre-filled syringe’ is removed from the pharmaceutical form (primary pharmaceutical form = suspension for injection)

-          Section 5.1: corrections of several typosSections 6.3, 6.4, 6.5, 6.6 &

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:23-07-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 5.1 : updated with effectiveness data against vaccine type and serotype 19A & immunogenicity data for serotype 19A

Section 10 : updated date of revision of text

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:23-04-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 - effects of paracetamol and ibuprofen used prophylactically on fever and immune responses following primary vaccination and a booster dose of Synflorix.

Section 10 – date update

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:25-09-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 5.1 – update with data from FinIP study

Section 10 – updated date

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:24-07-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8  - to include Kawasaki disease with a frequency of ‘Very rare’.

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:20-02-2014

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

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:21-02-2014

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

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:20-02-2014

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.

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:27-01-2014

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

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:25-11-2013

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

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:19-09-2013

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

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:28-06-2013

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

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:30-05-2013

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

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:25-10-2012

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

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:08-10-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Removal of Black Triangle

10.  Revision date changed

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:01-02-2012

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 

Reasons for adding or updating:

  • Correction of spelling/typing errors

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

Legal Category:POM

Black Triangle (CHM): YES

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:08-08-2011

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

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:24-01-2011

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

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES