Difflam Spray 0.15% w/v, Oromucosal Spray
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 April 2021
File name
patient-information-leaflet-015-3M-ie-cleannew.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 29 March 2021
File name
Difflam-spc-spray-pr1717658rtq2-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 29 March 2021
File name
Difflam-pil-015-pr1717658rtq-ie.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 12 December 2018
File name
ie-spc-difflam-spray-mahtransfer-clean.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 06 December 2018
File name
ie-pl-difflam-spray-mahtransfer-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 05 December 2018
File name
ie-spc-difflam-spray-mahtransfer-clean.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 24 October 2016
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
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 29 May 2014
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 29 May 2014
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 21 August 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 2: The quantities per puff of methyl parahydroxybenzoate and ethanol has been added
In section 4.4: Addition warning regarding methyl hydroxybenzoate and propyl hydroxybenzoate has been added. Reference to delayed allergic reactions.
In section 4.8: The format listing side effects has changed.
In section 5.1: The ATC Code has changed
In section 10: The date of revision has been changed.
Updated on 21 August 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 2: The quantities per puff of methyl parahydroxybenzoate and ethanol has been added
In section 4.4: Addition warning regarding methyl hydroxybenzoate and propyl hydroxybenzoate has been added. Reference to delayed allergic reactions.
In section 4.8: The format listing side effects has changed.
In section 5.1: The ATC Code has changed
In section 10: The date of revision has been changed.
Updated on 21 March 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 21 March 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Free text change information supplied by the pharmaceutical company
Updated on 10 March 2011
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: change of date of revision to Feb 2011
Updated on 10 March 2011
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: change of date of revision to Feb 2011
Updated on 14 April 2009
Reasons for updating
- Change to section 8 - MA number
- Change to section 7 - Marketing authorisation holder
- Correction of spelling/typing errors
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 14 April 2009
Reasons for updating
- 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
Updated on 14 April 2009
Reasons for updating
- Change to section 8 - MA number
- Change to section 7 - Marketing authorisation holder
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Updated on 14 April 2009
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 12 September 2006
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
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
Updated on 12 July 2005
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Supply through pharmacy only
Updated on 12 July 2005
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Updated on 04 June 2003
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 04 June 2003
Reasons for updating
- New SPC for new product
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1