Bramitob Nebuliser Solution
Last Updated on eMC 15-Sep-2015 View document | Chiesi Limited Contact details
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 15-Sep-2015 and displayed until Current
Reasons for adding or updating:
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 01-Jul-2015
Legal Category:POM
Black Triangle (CHM): NO
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-Dec-2014 and displayed until 15-Sep-2015
Reasons for adding or updating:
- Change to section 4.8 - Undesirable effects - how to report a side effect
Date of revision of text on the SPC: 01-Nov-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
In section 4.8 Addition of 'Reporting of suspected adverse reactions' Section
Updated on 24-Oct-2013 and displayed until 16-Dec-2014
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: 01-Jul-2013
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
- In section 4.4 modest and reversible hypoacusia changed to modest hypoacusia
- In section 4.8 productive cough changed from common to uncommon
Updated on 02-Nov-2011 and displayed until 24-Oct-2013
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC: 21-Oct-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Addition of further drug delivery detailsUpdated on 05-Sep-2011 and displayed until 02-Nov-2011
Reasons for adding or 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
Date of revision of text on the SPC: 28-Aug-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Addition of LC Sprint nebuliser and Pari Boy Sx compressor and changes to undesirable effects.Updated on 03-May-2011 and displayed until 05-Sep-2011
Reasons for adding or updating:
- Change to section 4.7 - Effects on Ability to Drive and Use Machines
- Change to section 4.8 - Undesirable Effects
- 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
Date of revision of text on the SPC: 28-Mar-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Sections 4.2, 4.4, 4.5, 4.7 & 4.8 updated.Updated on 05-Aug-2009 and displayed until 03-May-2011
Reasons for adding or updating:
- Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC: 23-Mar-2009
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Pack sizes updated to include full range.Updated on 02-Mar-2009 and displayed until 05-Aug-2009
Reasons for adding or updating:
- Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC: 22-Dec-2008
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Company name change from Trinity-Chiesi Pharmaceuticals Ltd to Chiesi LtdUpdated on 28-Jan-2009 and displayed until 02-Mar-2009
Reasons for adding or updating:
- New SPC for new product
Legal Category:POM
Black Triangle (CHM): NO
Chiesi Limited
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG
0800 009 2329
Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Active ingredients
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