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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (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: 06/05/2010
SPC Betnovate RD Cream

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 06/05/2010 and displayed until Current
Reasons for adding or updating:
  • 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:   31-Mar-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



1.                   TRADE NAME OF THE MEDICINAL PRODUCT

 

Betnovate RD (Ready Diluted) cream 0.025% w/w Cream

 

2.             QUALITATIVE AND QUANTITATIVE COMPOSITION

 

                Betamethasone 0.025% w/w (as Betamethasone valerate).

                Also contains Cetostearyl alcohol 7.2% w/w and chlorocresol 0.1% w/w

 

For a full list of excipients, see section 6.1

 

3.             PHARMACEUTICAL FORM

 

                Cutaneous Cream.

A white homogenous aqueous based cream.

Updated on 30/10/2008 and displayed until 06/05/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 07/01/2004 and displayed until 30/10/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Updated on 03/07/2003 and displayed until 07/01/2004
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 19/06/2003 and displayed until 03/07/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Betamethasone Valerate

Versions

 
06/05/2010 to Current
30/10/2008 to 06/05/2010
07/01/2004 to 30/10/2008
03/07/2003 to 07/01/2004
19/06/2003 to 03/07/2003
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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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