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sanofi-aventis
Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: IEmedinfo@sanofi-aventis.com
Summary of Product Characteristics last updated on medicines.ie: 03/02/2011
SPC Vallergan Oral Solution

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 03/02/2011 and displayed until Current
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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   26-Feb-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Change to 4.2 - to include children over 2 yrs
Change to 4.3 - to include pregnant women (1st trimester or nursing mothers)
Change to 4.4 - to include alergic manifestations
Change to 4.6 - to include risk of malformations & risk of foetotoxicity
Change to 4.8 - to include skin and eye undesirable effects
Updated on 01/09/2009 and displayed until 03/02/2011
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Addition of polypropylene child proof cap.
Updated on 06/08/2008 and displayed until 01/09/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 03/04/2008 and displayed until 06/08/2008
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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 Posology and Method of administration
Section 4.3 Contraindications
Section 4.4 Special Warnings and precautions for use
Section 4.5 Interactions with other medicinal products and other forms of interaction
Section 4.6 Pregnancy and lactation
Section 4.7 Effects on ability to dive and use machines
Section 4.8 Undesirable effects
Section 10 Date of (Partial) Revision of Text
Updated on 21/03/2007 and displayed until 03/04/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update
Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Section 10 - Date of Revision
Updated on 17/08/2006 and displayed until 21/03/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Updates to
Section 1 - Change in product name
Section 2 - Additional excipients listed
Section 10 - Date of Revision
Updated on 16/05/2005 and displayed until 17/08/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 11/04/2005 and displayed until 16/05/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Updated on 14/12/2004 and displayed until 11/04/2005
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Updated on 20/06/2003 and displayed until 14/12/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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