Chiesi Limited

Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY
Telephone: +44 (0) 161 488 5555
Fax: +44 (0) 161 488 5566
WWW: http://www.chiesi.uk.com
Medical Information e-mail: medinfo@chiesi.uk.com
Medical Information Fax: +44 (0) 161 488 5566

Summary of Product Characteristics last updated on the eMC: 02/11/2011
SPC Bramitob Nebuliser Solution

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 02/11/2011 and displayed until Current
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 details
Updated on 05/09/2011 and displayed until 02/11/2011
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 03/05/2011 and displayed until 05/09/2011
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 05/08/2009 and displayed until 03/05/2011
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 02/03/2009 and displayed until 05/08/2009
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 Ltd
Updated on 28/01/2009 and displayed until 02/03/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics

 
   tobramycin