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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 04/05/2010
SPC Flixonase Allergy Relief Nasal Spray

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 04/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Oct-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 6.1

The excipient name update - from Dispersible Cellulose (Avicel RC591) to Microcrystalline Cellulose and Carboxymethylcellulose (Carmellose) Sodium USNF (Avicel RC591)
Updated on 31/10/2008 and displayed until 04/05/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   10/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 1    Flixonase Allergy Relief 50 micrograms per dose Nasal Spray

 

Section 2    Each actuation delivers 100mg of suspension containing 50 micrograms of fluticaasone propionate

 

                    Excipients: also includes 20 micrograms of Benzalkonium Chloride per spray

 

                    For a full list of excipients, see section 6.1

 

 

(Changes are in bold)

 

Updated on 16/03/2006 and displayed until 31/10/2008
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 28/10/2004 and displayed until 16/03/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 07/01/2004 and displayed until 28/10/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Fluticasone Propionate

Versions

 
04/05/2010 to Current
31/10/2008 to 04/05/2010
16/03/2006 to 31/10/2008
28/10/2004 to 16/03/2006
07/01/2004 to 28/10/2004
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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