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Merck Sharp & Dohme Ireland (Human Health) Limited
Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 26/08/2011
SPC SINGULAIR Paediatric 5 mg Chewable Tablets

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 26/08/2011 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   13-Jul-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Correction of minor typos
Updated on 25/07/2011 and displayed until 26/08/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Updated side effects
Updated on 01/09/2010 and displayed until 25/07/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02-Aug-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Updated side effects - Section 4.8

 
Updated on 17/11/2009 and displayed until 01/09/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   30-Sep-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Approval of II/49 (update to 4.8 of SPC)
Addition of side effects: epistaxis/pyrexia

 
Updated on 01/12/2008 and displayed until 17/11/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.8 has been updated to include anxiety.
Updated on 03/07/2008 and displayed until 01/12/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Amend section 4.8 Undesirable effects
Updated on 21/02/2008 and displayed until 03/07/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The changes to the SPC are to Section 4.8 Undesirable Effects which has been amended to include tremor and depression .
Updated on 21/02/2008 and displayed until 21/02/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The changes to the SPC are to Section 4.8 Undesirable Effects which has been amended to include tremor and depression

Updated on 09/01/2008 and displayed until 21/02/2008
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Montelukast Sodium