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Allen & Hanburys Ltd
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: 05/01/2012
SPC Seretide 50, 125, 250 Evohaler

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 05/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section

Summary of change

4.4

Minor typographical changes

4.5

Minor typographical changes

4.8

Substantial amendments to adverse events table with regards to frequency of adverse events

10.

Approval date changed to 21 December 2011
Updated on 19/09/2011 and displayed until 05/01/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   14-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section

Summary of change

4.4

Addition of psychiatric adverse drug reactions

4.8

Addition of depression and aggression to adverse event table

10.

Approval date changed to 31 August 2011
Updated on 23/03/2011 and displayed until 19/09/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section

Summary of change

4.4

Deletion of text

Addition of information on paediatric population

4.6

Addition of information on fertility, pregnancy and lactation

10.

Approval date changed to 16 January 2011
Updated on 15/09/2010 and displayed until 23/03/2011
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • 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:   25-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.2 Replacement of “mcg”with “microgram”$04.4 Replacement of “mcg”with “microgram”$0$04.5 Replacement of “mcg”with “microgram”$0$05.1 Replacement of “mcg”with “microgram”$0$05.2 Replacement of “mcg”with “microgram”$0$05.3 Removal of "xinafoate"$0$09. Renewal date changedto 06 June 2010$0$010. Approval date changed to 25 Aug 2010$0$0$0$0
Updated on 19/08/2010 and displayed until 15/09/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.2 Update to Recommended Doses section for children 4 years and older$05.2 Inclusion of section on Paediatric population$0$010 Date changed to 06 July 2010$0
Updated on 01/04/2010 and displayed until 19/08/2010
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
Date of revision of text on the SPC:   24-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - Added "Each single actuation of Seretide provides:", which was deleted by mistake in previous submission

Section 4.8 - Updated with information on paediatric population.

Section 10 - 24 March 2010
Updated on 23/03/2010 and displayed until 01/04/2010
Reasons for adding or updating:
  • 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:   04-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 - 2 years

Section 10 -  04 February 2010
Updated on 09/12/2009 and displayed until 23/03/2010
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:   19-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Addition of paragraph at the end of section - "Concomitant use of systemic ketoconazole..."

Section 4.5 - Addition of information on Salmeterol

Section 10 -  Change of revision date
Updated on 15/01/2008 and displayed until 09/12/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1:  Update in-line with EU QRD template (Accuhaler & Evohaler)
Section 4.2: Update to instuctions for use and storage (Evohaler only)
Secton 5.2: Update in line with more recent FP bioavilability data (Accuhaler & Evohaler)
Section 6.4: Update to instuctions for use and storage (Evohaler only)
Updated on 11/09/2007 and displayed until 15/01/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 Clinical trial data
Section 4.8 Clinical trial data
Updated on 05/12/2006 and displayed until 11/09/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 27/11/2006 and displayed until 05/12/2006
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
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 29/09/2006 and displayed until 27/11/2006
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
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 04/09/2006 and displayed until 29/09/2006
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 13/09/2005 and displayed until 04/09/2006
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 14/04/2005 and displayed until 13/09/2005
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 27/01/2005 and displayed until 14/04/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 14/01/2005 and displayed until 27/01/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 29/03/2004 and displayed until 14/01/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Updated on 19/12/2002 and displayed until 29/03/2004
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 29/05/2002 and displayed until 19/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 22/05/2002 and displayed until 29/05/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 08/05/2002 and displayed until 22/05/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 30/04/2002 and displayed until 08/05/2002
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 16/08/2001 and displayed until 30/04/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 12/07/2000 and displayed until 16/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  fluticasone propionate
  salmeterol xinafoate