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: 27/05/2011
SPC Atimos Modulite 12 micrograms inhaler

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 27/05/2011 and displayed until Current
Reasons for adding or 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 4.8 - Undesirable Effects
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Further information added to sections 4.2, 4.4, 4.8 and 6.5
Updated on 03/02/2011 and displayed until 27/05/2011
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   31-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Black Triangle has been removed.
Updated on 27/10/2010 and displayed until 03/02/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Date of revision updated
Updated on 25/02/2009 and displayed until 27/10/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   02-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

In section 7, the name of the MAH has changed from Trinity-Chiesi Pharmaceuticals Ltd to Chiesi Ltd. 
Updated on 21/07/2008 and displayed until 25/02/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics

 
   formoterol fumarate dihydrate