Bramitob Nebuliser Solution
*Company:
Chiesi LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 06 December 2023
File name
Bramitob CP0005- 13.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
updating the manufacturer address within the Bramitob package leaflet.
Updated on 24 January 2022
File name
Bramitob SmPC CS0013-12_IE.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 January 2022
File name
Bramitob PIL_CP0005-12.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 16 May 2019
File name
Bramtob IE CP0066-1 (2).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 16 May 2019
File name
Bramitob 300mg IE CS0013-11.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:Product subject to medical prescription which may not be renewed (A)
Updated on 07 May 2019
File name
Bramitob IE CP0005-10.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 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- 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 03 May 2019
File name
Bramitob 300mg IE CS0013-10.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type II variation.
Section 4.5 of the SmPC has been updated regarding the concomitant use with mannitol by clarifying that it only refers to intravenous mannitol and not to mannitol for inhalation. In addition, the SmPC (section 4.3)
4.3 Contraindications- listed in section 6.1. has been added
4.5 Interaction with other medicinal products and other forms of interaction - intravenous and oral mannitol has been added
6.6 Special precautions for disposal and other handlings - Any waste material should be discarded after use changes to Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
10. DATE OF REVISION OF THE TEXT July 2015 changed to March 2019
Updated on 13 November 2015
File name
PIL_14408_470.pdf
Reasons for updating
- New PIL for new product
Updated on 13 November 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 15 September 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 September 2015
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 – Marketing Authorisation Holder - Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY UK Changed to Chiesi Limited, 333 Styal Road, Manchester, M22 5LG UK
Section 10 – Date of revision of the Text – November 2014 changed to July 2015
Updated on 16 December 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 December 2014
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 12 November 2013
Reasons for updating
- Change to side-effects
Updated on 22 October 2013
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.4 (special warnings and precautions for use) modest and reversible hypoacusia changed to modest hypoacusia.
In section 4.8 (undesirable effects), productive cough changed from common to uncommon.
Updated on 29 February 2012
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
Updated on 02 November 2011
Reasons for updating
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 August 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 05 August 2011
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Further clinical trial info provided in Undesirable effects section.
Addition of new undesirable effects and change to incidences of others.
Updated on 29 July 2011
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to date of revision
- Change to MA holder contact details
- Change to further information section
- Improved electronic presentation
Updated on 03 May 2011
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 September 2009
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 September 2009
Reasons for updating
- New PIL for medicines.ie