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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited
7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299
Summary of Product Characteristics last updated on medicines.ie: 25/11/2011
SPC Gaviscon Infant

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 25/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   23-Nov-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Included the following in section 4.3:

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1

Updated on 15/05/2007 and displayed until 25/11/2011
Reasons for adding or updating:
  • Change to marketing authorisation holder address
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   02/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 1.  Name of Medicinal Product has been changed to Gaviscon Infant, Powder for Oral Suspension
 
Section 2.  Qualitative and Quantitative Composition has been expanded to state that each dose contains 21mg sodium.
 
Section 3. Pharmaceutical Form has been amended to read 'Powder for Oral Suspension'.
 
Section 7.  Address of marketing authorisation holder has been changed to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Updated on 10/08/2004 and displayed until 15/05/2007
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 24/06/2003 and displayed until 10/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie
Updated on 16/06/2003 and displayed until 24/06/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Magnesium Alginate
   Sodium Alginate

Versions

 
25/11/2011 to Current
15/05/2007 to 25/11/2011
10/08/2004 to 15/05/2007
24/06/2003 to 10/08/2004
16/06/2003 to 24/06/2003
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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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