Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules
*Company:
Novartis Ireland 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 16 August 2021
File name
Ultibro Breezhaler REG PIL PF 21-0202_August 2021_Clean.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 16 August 2021
File name
Ultibro_REG SPC_PF21-0202_August 2021_IPHA.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 November 2020
File name
Ultibro Breezhaler REG PIL PF 20-0178_November 2020_Clean.pdf
Reasons for updating
- Change to other sources of information section
Updated on 24 November 2020
File name
Ultibro_Breezhaler_REG SPC_PF20-0178_November 2020_IPHA.pdf
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 January 2020
File name
Ultibro Breezhaler REG PIL PF 19-0280_December 2019_IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 11 September 2019
File name
Ultibro_Breezhaler_REG PIL_PF19-0122_June 2019_Clean_IPHA.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 14 June 2019
File name
Ultibro_Breezhaler_REG PIL_PF19-0122_June 2019_Clean_IPHA.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 14 June 2019
File name
Ultibro_Breezhaler_REG SPC_PF19-0122_June 2019_Clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 April 2019
File name
03.04.2019_Ulitibro_IPHA_PF19-0068.pdf
Reasons for updating
- Change to further information section
Updated on 01 April 2019
File name
REG SPC_Ultibro_Breezhaler_PF 19-0068_IPHA.pdf
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)
Updated on 30 October 2018
File name
Ultibro Breezhaler_REG_PIl_1132622_A18_R91_p5_BKLT_X-4_IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 26 July 2018
File name
REG_Ultibro_Breezhaler_SmPC.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)
Updated on 08 June 2018
File name
Ultibro Breezhaler REG SmPC_PF18-0137_clean.docx
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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)
Updated on 10 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 February 2018
File name
PIL_15905_694.pdf
Reasons for updating
- New PIL for new product
Updated on 05 February 2018
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
Updated on 13 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 November 2017
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 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 6.3 - updated to read:
The inhaler in each pack should be disposed of after all capsules in that pack have been used.
Section 6.5 - Added detail on pack containing 90x1 hard capsules + 1 inhaler and deleted 90 multipack (3 packs of 30x1 and 3 inhalers) as this is being replaced.
Section 6.6 - updated to read:
The inhaler in each pack should be disposed of after all capsules in that pack have been used
Updated on 26 January 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 09 December 2016
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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 - revisions of some frequencies and addition of Dysphonia as new post-marketing ADR.
Section 5.1- addition of FLAME study (A2318) results.
Key points:
· Data on exacerbations versus salmeterol/fluticasone, as well as lung function, SGRQ, and pneumonia are included
· CHMP challenged the inclusion of data on:
o Severe exacerbations (outcome: included)
o Incidence of Pneumonia (outcome: included)
Updated on 19 November 2015
Reasons for updating
- Introduction of new pack/pack size
Updated on 28 October 2015
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Seciton 8 - addition of new MA numbers for new 10-pack and 150 multi-pack
Updated on 18 March 2015
Reasons for updating
- Change to marketing authorisation holder
Updated on 29 January 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 04 January 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 26 February 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Address of where to report suspected adverse events was simplified in line with revision to Annex V.
Updated on 09 December 2013
Reasons for updating
- New PIL for new product
Updated on 30 September 2013
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)