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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: 09/05/2011
SPC Karvol Decongestant Capsules

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 09/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   18-Apr-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
In section 2 (Qualitative & Quantitative composition)
Pine Oil Sylvestris changed to Pine Oil Sylvestris blend
Pumilio Pine Oil changed to Pumilio Pine Oil Blend
Updated on 30/03/2010 and displayed until 09/05/2011
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 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Mar-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
4.2 - separatiion of dosage instructions between adults and children/babies
4.3 - add the contraindication in babies under 3 months
4.6 - Seek doctors advice, do not use boiling water
7 - license transfered to Reckitt Benckiser
8 - PA number changed to 979/61/1
Updated on 03/03/2010 and displayed until 30/03/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   19-Feb-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
Updated for license renewal
Updated on 27/08/2007 and displayed until 03/03/2010
Reasons for adding or updating:
  • New SPC for medicines.ie

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