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Pandemrix suspension and emulsion for emulsion for injection

Last Updated on eMC 01-Aug-2013 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 01-Aug-2013 and displayed until Current

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Addition of black triangle

Date of revision of text on the SPC: 25-Jul-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Addition of Black Triangle
2    Minor correction
4.8    Updated with reporting of suspected adverse reactions (QRD9)
10    Updated with new date of revision of text

Updated on 03-Apr-2013 and displayed until 01-Aug-2013

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • 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-Mar-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.4  Updated with new information regarding risk of narcolepsy

4.8  Update to footnote regarding epidemiology studies

10.  Updated with new date of revision of text

Updated on 26-Oct-2012 and displayed until 03-Apr-2013

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

Section 10 - revision date changed

Updated on 17-Jan-2012 and displayed until 26-Oct-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: 19-Dec-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

4.4  Updated to include a warning on syncope
10   Revision date 19/12/2011

Updated on 16-Nov-2011 and displayed until 17-Jan-2012

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: 03-Nov-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

5.1 Updated with data from studies D-Pan-H1N1-009, -010 and -023 (12 month) in children ages 6 months to 17 years

10. Updated with new date of revision of text

Updated on 04-Oct-2011 and displayed until 16-Nov-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: 16-Sep-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

4.1 Restrictions on use in persons under 20 years of age
4.2 Cross-reference to additional 12-month data in Section 5.1
4.4 Updated information on incidence of narcolepsy and warning regarding use in persons under 20.
4.8 Addition of narcolepsy as a very rare adverse reaction following epidemiological studies in Sweden and Finland.
5.1 Addition of 12-months immunogenicity data following studies D-Pan-H1N1-007 and -008.
10.  Update date of approval

Updated on 05-Jul-2011 and displayed until 04-Oct-2011

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • 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: 17-Jun-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

4.4  Reference to data from epidemiological studies in Sweden/Finland and the risk of narcolepsy in children/adolescents
4.5 Immune responses from a study where a non-adjuvanted seasonal influenza vaccine was administered three weeks after the second dose of Pandemrix
10.  Date of approval

Updated on 04-Apr-2011 and displayed until 05-Jul-2011

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: 24-Mar-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

5.1 Update to include neutralizing immune response data for post dose 1 and post dose 2 in the studies Flu D-Pan H1N1-009, FLU D-Pan-H1N1-010 and FLU D-Pan-H1N1-023 covering individuals 6 months to 17 years of age, as well as persistence data (HI and neutralizing response) at Month 6 from study D-Pan-H1N1-023
10. revision of date 24/3/11

Updated on 22-Feb-2011 and displayed until 04-Apr-2011

Reasons for adding or updating:

  • 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: 21-Jan-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

5.1 Updated information from Studies -007 and -008.
6.6 Minor amends to instruction for use
10. Update to Date of Revision

Updated on 23-Sep-2010 and displayed until 22-Feb-2011

Reasons for adding or updating:

  • 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: 10-Sep-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

4.8

Updated with adverse event data from clinical trials: 6-35 months, 3-9 years and 10- 17 years of age

5.1

Updated with immunogenicity data from clinical trials: 6-35 months, 3-9 years and 10- 17 years of age

10.

Updated date of revision

Updated on 02-Sep-2010 and displayed until 23-Sep-2010

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 31-Aug-2010

Legal Category:POM

Black Triangle (CHM): YES

Updated on 20-Aug-2010 and displayed until 02-Sep-2010

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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: 19-Aug-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Switch to full MAA allowing use outside of a pandemic situation.  Licence means change to:
4.1
    
Therapeutic indications:  Prophyaxis of influenza caused by A (H1N1)v 2009 virus.
4.8 and 5.1 Updated with data from study D-PAN H1N1-008
6.6 update for instructions for mixing and administration

Updated on 04-Mar-2010 and displayed until 20-Aug-2010

Reasons for adding or updating:

  • 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-Feb-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.1 - To add the safety and immunogenicity data in children aged 3-9 years from two clinical studies (H1N1-010, H1N1-023) carried out in children aged from 3 to 17 years.

Section 4.8 - To add the safety and immunogenicity data in children aged 3-9 years from two clinical studies (H1N1-010, H1N1-023) carried out in children aged from 3 to 17 years.

Section 5.1 - To add the safety and immunogenicity data in children aged 3-9 years from two clinical studies (H1N1-010, H1N1-023) carried out in children aged from 3 to 17 years.

Section 10 -  New Date

Updated on 07-Jan-2010 and displayed until 04-Mar-2010

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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: 22-Dec-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.2 -Posology updated

Section 4.4 - Statement updated: "There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1) in children aged less than 6 months. There are limited data available from a clinical study with Pandemrix (H1N1) in healthy children aged from 10 to 17 years,"

Section 4.5 - Information on co-administration with Fluarix

Section 4.8-More information from clinical study added

Section 5.1 - Information on Adults aged 18-60 years updated and new section Children aged 10-17 years added

Section 10 - New revision date

Updated on 21-Dec-2009 and displayed until 07-Jan-2010

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: 12-Dec-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - Posology for Children aged from 6 months to 9 years updated

Section 4.4 -Added "Very limited data in children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses indicate an increase in the rates of injection site reactions and general symptoms (see section 4.8). In particular rates of fever (axillary temperature =38°C) may increase considerably after the second dose. Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) after each vaccination."

Section 4.8 -Adverse reactions for Children aged 3-9 years, Children aged 6-35 months and post-marketing surveillance updated.

Section 5.1 -Update information on children aged 6-35 months

Section 10 - New Date

Updated on 04-Dec-2009 and displayed until 21-Dec-2009

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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: 27-Nov-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - Posology updated based on data from D-Pan H1N1-008 study (post dose 1 in >60 years old) and D-Pan H1N1-009 study (post dose 1 (half dose) in 6 months-3 years old children)

Section 4.4 - Added "There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1) in children and adolescents aged from 3-17 years or in children aged less than 6 months. There are very limited data available from a clinical study with Pandemrix (H1N1) in healthy children aged from 6 to 35 months and limited data from a study with a version of Pandemrix containing H5N1 antigens in children aged from 3 to 9 years.

There are limited data available from clinical studies with Pandemrix (H1N1) in adults aged over 60 years and very limited data with Pandemrix (H1N1) or with a version of the vaccine containing H5N1 antigens in adults aged over 80 years. "

Section 4.5 - Added "Data obtained on co-administration of Pandemrix H1N1 with non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any significant interference in the immune response to Pandemrix H1N1. The immune response to Fluarix was satisfactory.

Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Pandemrix alone.

Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).

.

There are no data on co-administration of Pandemrix with other vaccines.

If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.
Section 4.8 - Added new information based on data from D-Pan H1N1-008 study (post dose 1 in >60 years old), D-Pan H1N1-009 study (post dose 1 (half dose) in 6 months-3 years old children), and post-marketing surveillance data.

Section 5.1 - Added new information based on data from D-Pan H1N1-008 study (post dose 1 in >60 years old) and D-Pan H1N1-009 study (post dose 1 (half dose) in 6 months-3 years old children).

Section 6.6 - Clarification around instructions for mixing and administration of the vaccine

Section 10 - New date

Updated on 20-Nov-2009 and displayed until 04-Dec-2009

Reasons for adding or updating:

  • 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 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 11-Nov-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.2-to reflect newly available results from a clinical study in adults 18-60 years of age (H1N1-007).
Section 4.5- to reflect newly available results from a clinical study in adults 18-60 years of age (H1N1-007).

Section 6.5-update the instructions for mixing and administration of the vaccine

Updated on 19-Oct-2009 and displayed until 20-Nov-2009

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

influenza vaccine (split virion, inactivated)

Legal categories

POM - Prescription Only Medicine

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