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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

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?
Summary of Product Characteristics last updated on the eMC: 03/05/2011
SPC Clenil Modulite 50, 100, 200, 250 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 03/05/2011 and displayed until Current
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 10 date of revision of the text
Date of revision of text on the SPC:   13-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Addition of information to sections 4.4 and 4.8 regarding psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (predominantly in children). Frequency unknown.
Updated on 02/11/2009 and displayed until 03/05/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Removal of Black Triangle
Date of revision of text on the SPC:   09-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • The Black Triangle has been removed.
  • In section 4.8 (Undesirable effects), cough has been added in relation to paradoxical bronchospasm
Updated on 26/02/2009 and displayed until 02/11/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   26-Nov-2008
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 17/11/2008 and displayed until 26/02/2009
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

 
  beclometasone dipropionate