DIFFLAM ORAL RINSE
- Name:
DIFFLAM ORAL RINSE
- Company:
Mylan IRE Healthcare Limited
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/12/18

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Mylan IRE Healthcare Limited

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 6 December 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 5 December 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 24 October 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 24 October 2016 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 4.8: Hypersensitivity has been added to immune system disorders. The ADR statement has been updated.
In section 4.9: Information has been added.
In section 10: The date of revision
Updated on 24 October 2016 PIL
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.8: Hypersensitivity has been added to immune system disorders. The ADR statement has been updated.
In section 4.9: Information has been added.
In section 10: The date of revision
Updated on 16 May 2016 SmPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 6.5: Information that the graduated measuring cup has changed from 20ml to 30ml
In section 10: The date of revision has been changed.Updated on 16 May 2016 PIL
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 6.5: Information that the graduated measuring cup has changed from 20ml to 30ml
In section 10: The date of revision has been changed.Updated on 29 May 2014 PIL
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.4: these has been additional warnings added in relation to allergic reactions and to bronchospasm
In section 4.8: additional side effect of anaphylactic reaction has been added. Reporting information of adverse reaction to the IMB has been added
In section 5.1: Change in pharmacotherapeutic group. Additional information regarding the mode of action added. Pharmacodynamic effect information has been added. Clinical efficacy and safety text added.
In section 10: the date of revision has changed.
Updated on 29 May 2014 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 4.4: these has been additional warnings added in relation to allergic reactions and to bronchospasm
In section 4.8: additional side effect of anaphylactic reaction has been added. Reporting information of adverse reaction to the IMB has been added
In section 5.1: Change in pharmacotherapeutic group. Additional information regarding the mode of action added. Pharmacodynamic effect information has been added. Clinical efficacy and safety text added.
In section 10: the date of revision has changed.
Updated on 21 March 2011 SmPC
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 21 March 2011 PIL
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Free text change information supplied by the pharmaceutical company
Updated on 10 March 2011 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 10: the date of revision has changed to Feb 2011
Updated on 10 March 2011 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 10: the date of revision has changed to Feb 2011
Updated on 14 April 2009 SmPC
Reasons for updating
- Correction of spelling/typing errors
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 14 April 2009 PIL
Reasons for updating
- Correction of spelling/typing errors
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Free text change information supplied by the pharmaceutical company
Updated on 12 September 2006 SmPC
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 12 September 2006 PIL
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
Updated on 4 June 2003 SmPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 4 June 2003 PIL
Reasons for updating
- New SPC for new product