Brimica Genuair 340 micrograms /12 micrograms inhalation powder
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 12 October 2023
File name
Brimica PIL clean approved Sept 23.pdf
Reasons for updating
- Change to improve clarity and readability
Updated on 29 September 2023
File name
Brimica PIL clean approved Sept 23.pdf
Reasons for updating
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
Deletion of QR code
Updated on 06 April 2023
File name
Brimica SPC clean approved Dec 22.pdf
Reasons for updating
- 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 7 - MAH holder updated
Section 10 - Date of revision updated
Updated on 06 April 2023
File name
Brimica PIL clean approved Dec 22.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
MAH holder changed
Date of revision updated
Updated on 04 October 2021
File name
ie-leaflet Almiral BR name change - Clean - August 21.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Section 4 - Possible side effects - typo corrected in the word Wheezing
Section 4 - AE reporting details for HPRA updated
Section 6 - Manufacturer address updated
Updated on 01 October 2019
File name
ie-leaflet renewal and psusa 23-8-19 clean.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 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Increased prominence to side-effects where you should stop taking the medicne and contact your doctor immeidiately.
Fomatting and administrative changes including the container wording change from 'pouch' to 'bag'
Updated on 01 October 2019
File name
ie-spc 23-8-19 Psusa and renewal clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Fomatting and administrative changes including the container wording change from 'pouch' to 'bag'
Updated on 06 September 2018
File name
ie-leaflet IFU 30-8-18 clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 06 September 2018
File name
ie-spc IFU clean 22-2-18 rev.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
File name
ie-leaflet IFU clean 22-2-18.pdf
Updated on 26 June 2018
File name
ie_spc_Brimica_IFU_clean_22_2_18 rev.docx
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Correction to formatting error
Updated on 10 May 2018
File name
ie_spc_Brimica_IFU_clean_22_2_18.docx
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 Instructions for Use have been moved from section 4.2 to section 6.6 and updated.
Updated on 04 May 2018
File name
ie-leaflet IFU clean 22-2-18.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to improve clarity and readability
Updated on 01 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 February 2018
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- 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
Update to section 5.2 Pharmacokinetic properties of the SmPC, due to new pharmacokinetic data (addition of effective half-life) from a clinical study and simplification of the ADR footnotes in 4.8 Undesirable effects (without adding or removing ADRs).
Updated on 28 September 2017
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Update to Section 5.1 Pharmacodynamic properties
New information added on lung volumes, exercise endurance and physical activity following an 8-week parallel, randomised, placebo-controlled clinical study in COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Updated on 21 March 2017
File name
PIL_16348_897.pdf
Reasons for updating
- New PIL for new product
Updated on 21 March 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 4.8 Undesirable effects:
“Angina pectoris” has been added to the adverse reactions under ‘Cardiac disorders’ with a frequency ‘uncommon’.
Updated on 21 March 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 September 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 as follows:
Section 4.8 Undesirable effects
Addition of Anaphylactic reaction (frequency not known) and Stomatitis (uncommon).
Updated on 20 September 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change of distributor details
Updated on 23 June 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 23 June 2016
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
Updated on 10 May 2016
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
This update is to change the colour of the protective cap and dosage button for the inhaler device from turquoise to orange.
The sections affected are 3, 4.2 and 6.5.
Updated on 10 May 2016
Reasons for updating
- Change to further information section
- Change to appearance of the medicine
Updated on 02 June 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 02 June 2015
Reasons for updating
- New PIL for new product