Striverdi Respimat 2.5 microgram, solution for inhalation
*Company:
Boehringer Ingelheim LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 April 2023
File name
PIL 316416-05 14.02.2023 - PIP046434-005 - Cropped.pdf
Reasons for updating
- Removal of Black Inverted Triangle
- Change to date of revision
Updated on 21 April 2023
File name
R1f-IE-SPC-8.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 December 2022
File name
PIL 316416-04 22.07.2022 - PIP046434-004 - Cropped.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - marketing authorisation holder
Updated on 23 December 2022
File name
R1f-IE-SPC-7.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
• Section 4.2: Update to “Method of administration”.
• Section 6.3: Updated to include minor editorial changes.
• Section 7: Updated to remove “-D” from Marketing Authorisation Holder address.
• Section 10: The date of revision has been updated to December 2022 to align with the approval date 15/12/2022.
Updated on 12 January 2021
File name
PIL 316416-02 24.07.2020 PIP046434-002 AMT99364 - SK & DP reviewed OK - REDUCED - CROPPED.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 11 January 2021
File name
R1f-E-SPC-6 - Approved.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Section 4.2: The sentence “Respimat is an inhaler device that generates a spray for inhalation.” has been included in the SmPC under the section ‘Instruction for use’ to provide the user/patient a clear information of the purpose of the device (Respimat).
- Section 4.8: Update to the Irish Adverse Events reporting details.
- Section 10: Updated to 18 December 2020.
Updated on 02 December 2019
File name
PIL 316416-01- 22.10.2018 PIP046434-001-AMT 88083 - CROPPED.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- 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 looks like and pack contents
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to improve clarity and readability
Updated on 02 December 2019
File name
R1f-E-SPC-4 for medicines.ie.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2 – Posology and method of administration: to include the instructions for use for the re-usable device
Section 6.3 – Shelf life: to include an in-use shelf life for the inhaler and recommended use: 6 cartridges per inhaler
Section 6.5 – Nature and contents of container: to include the new pack sizes
Section 10 – Date of revision
Updated on 16 November 2018
File name
3098001-05 15-AUG-2018 PIP030180-005 reduced and cropped.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 - date of revision
- Change to other sources of information section
Updated on 08 November 2018
File name
R1f-E-SPC-5.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The changes are:
- addition of the term actuation in place of/alongside puff (sections 2, 4.2 and 6.5)
- Inclusion of information on the excipient benzalkonium chloride (sections 2 and 4.4)
- Revised dates (sections 9 and 10)
Some minor editorial changes/corrections of typographical errors have also been made to section 4.5 heading, section 4.8 AE reporting, section 5.1, section 6.2 and section 8 heading.
Updated on 21 June 2016
File name
PIL_16034_143.pdf
Reasons for updating
- New PIL for new product
Updated on 21 June 2016
Reasons for updating
- Change to improve clarity and readability
Updated on 23 March 2016
Reasons for updating
- Change of trade or active ingredient name
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
Updated on 22 March 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 March 2016
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2 updated in respect of the User Instructions.
In addition, the pharmaceutical form has been updated from ‘solution for inhalation’ to ‘inhalation solution’ (sections 1; 3).
Section 10: Revision date has been changed to March 2016
Updated on 14 October 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The change to the SPC was to update the details for reporting of suspected adverse reactions in section 4.8. (IMB details amended to HPRA details) as required by HPRA.
Section 10 date of revision has been updated to reflect the date of approval.
Updated on 14 October 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 02 July 2014
Reasons for updating
- New PIL for new product
Updated on 01 July 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)