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McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
Medical Information Direct Line: 01344 864042
Medical Information e-mail: medinfo@its.jnj.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 09/06/2011
SPC Calpol Six Plus Fast Melts (Packsize 12)

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 09/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   06-Jun-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Variation to update sections 4.2 (Posology and administration) and 4.4 (Special warnings) to include paediatric posology requested by MHRA with regards to paracetamol containing products.
Updated on 26/10/2009 and displayed until 09/06/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   05-Oct-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to sections

4.1 of the SPC to include the indications of colds and influenza and to harmonise the other indications throughout the range.

4.8 of the SPC to add ‘anaphylactic reactions’ as a possible side-effect

Other updates to several sections of the SPC in line with current QRD template/regulatory guidelines and rephrasing of the storage conditions to some licences to align with the wording used across the current Calpol 6+ product range.

Updated on 08/05/2009 and displayed until 26/10/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Mar-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Renewal of product licence – SPC has been updated to reflect this renewal date and date of revision.

 
Updated on 24/04/2008 and displayed until 08/05/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   04/2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to MA as a result of integration
Updated on 08/08/2007 and displayed until 24/04/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2005
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 10: Change to the revision of the text
Updated on 25/09/2006 and displayed until 08/08/2007
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations
Date of revision of text on the SPC:   07/2005
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The original SPC for six plus fast melts has been seperated into two due to different packsizes and legal catagories

Active Ingredients/Generics

 
  paracetamol