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Novartis Ireland Limited

Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, Ireland
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 13/11/2017
SPC Ultibro Breezhaler

When a pharmaceutical company changes an SPC or PIL, 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 13/11/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   24-Oct-2017
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 09/12/2016 and displayed until 13/11/2017
Reasons for adding or 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
Date of revision of text on the SPC:   10-Nov-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.4 - Clarified wording on paradoxical brochospasm
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 28/10/2015 and displayed until 09/12/2016
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
Date of revision of text on the SPC:   09-Oct-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 6.5 - addition of new 10-pack and 150 multi-pack
Seciton 8 - addition of new MA numbers for new 10-pack and 150 multi-pack
Updated on 29/01/2015 and displayed until 28/10/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   21-Jan-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 7 - MAH contact details changed from Horsham to Frimley address
Updated on 04/01/2015 and displayed until 29/01/2015
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   16-Dec-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8 - wording on hypersensitivity and angioedema updated.
Updated on 26/02/2014 and displayed until 04/01/2015
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   23-Jan-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 6.3 Shelf Life increased freom 18 months to 2 years.

Section 4.8 - Address of where to report suspected adverse events was simplified in line with revision to Annex V.
Updated on 30/09/2013 and displayed until 26/02/2014
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Indacaterol maleate
   Glycopyrronium bromide