Nicotinell Cool Mint 2mg medicated chewing gum
- Name:
Nicotinell Cool Mint 2mg medicated chewing gum
- Company:
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through general sale
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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
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Company Products
When a pharmaceutical company changes any document, 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 24 December 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Update to the excipient warnings
Updated on 24 December 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Update to excipient warnings
Updated on 21 December 2020 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Supply through general sale
Updated on 4 June 2020 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
The shelf life has been increased to 30 months.
Updated on 30 April 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through general sale
Updated on 27 October 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 27 October 2016 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 3 October 2016 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 3 October 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through general sale
Updated on 16 May 2016 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 4 September 2015 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Addition of legal category
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 2
“with known effect” added
Section 4.2
Information regarding method of use moved under separate heading “Method of administration”
Headings amended
Section 4.3
“listed in section 6.1”
Section 4.8
AE data tabulated and adverse event reporting details added
Section 9
Date of last renewal amended to 25 May 2010
Section 10
Date of revision amended from 1st July 2014 to 25th August 2015
Legal Category amended to Supply though general sale
Updated on 8 July 2014 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
SPC Update – Nicotinell Cool Mint 2mg medicated chewing-gum – 1 July 2014
Section 7
Address changed to Camberley.
Section 10
Change of date from 20 January 2012 to 1 July 2014.
Updated on 27 March 2012 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 9
Date of last renewal date changed from 25 May 2005 to 20 January 2012
Section 10
Change date from September 2010 to 20 January 2012
Updated on 8 March 2011 SPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Supply through general sale