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Novartis Ireland Limited

Novartis Ireland Limited
Beech House, Beech Hill Office Campus, Clonskeagh, Dublin 4,
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 08/12/2010
SPC Voltarol 75mg/3ml ampoules

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 08/12/2010 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   31-Oct-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Typo's corrected throughout document and readibility improved
Updated on 25/06/2008 and displayed until 08/12/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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
Date of revision of text on the SPC:   02/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Changes to Section 4.2,4.3,4.4,4.5,4.8
Updated on 30/11/2006 and displayed until 25/06/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   10/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.8 (Undesirable effects) Text edited
Updated on 17/11/2006 and displayed until 30/11/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The changes follow a BPI update
Updated on 01/06/2006 and displayed until 17/11/2006
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 6.4 - Special precautions for storage
Updated on 18/05/2005 and displayed until 01/06/2006
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 26/06/2003 and displayed until 18/05/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Diclofenac Sodium

Versions

 
08/12/2010 to Current
25/06/2008 to 08/12/2010
30/11/2006 to 25/06/2008
17/11/2006 to 30/11/2006
01/06/2006 to 17/11/2006
18/05/2005 to 01/06/2006
26/06/2003 to 18/05/2005
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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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