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Nycomed UK Ltd
Nycomed UK Ltd, 3 Globeside Business Park, Fieldhouse Lane, MARLOW, Buckinghamshire, SL7 1HZ, UK
Telephone: +44 (0)1628 646 400
Fax: +44 (0)1628 646 401
WWW: http://www.nycomed.com
Medical Information Direct Line: +44 (0) 800 633 5797
Medical Information e-mail: medinfo@nycomed.com
Medical Information Fax: +44 (0)1628 646 534

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: 09/06/2011
SPC Alvesco 80 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 09/06/2011 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
Date of revision of text on the SPC:   18-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of wording to sections 4.4 and 4.8 following an MHRA request regarding "Risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drug reactions to intranasal corticosteroids".
Updated on 25/02/2010 and displayed until 09/06/2011
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

6 April 2004/28th September 2009


10.     DATE OF REVISION OF THE TEXT

19 February 2009 11th November 2009

 
Updated on 23/11/2009 and displayed until 25/02/2010
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   11-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 1, the Black Triangle Symbol has been removed.
Updated on 21/04/2009 and displayed until 23/11/2009
Reasons for adding or updating:
  • 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:   19-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8, Undesirable Effects, has been updated to change the frequency of some of the adverse events.
Updated on 02/02/2009 and displayed until 21/04/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   24-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Changes to Sections 4.2 and 5.1 to clarify the high dose regimen following a Commission Decision after repeat use MRP.
Updated on 25/02/2008 and displayed until 02/02/2009
Reasons for adding or 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
  • Company name change or merger
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 7: Change of name of MAH
Section 8: Change of company number reflecting change of name of MAH
Section 10: Updated date of text revision
Updated on 31/05/2007 and displayed until 25/02/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/05/2007 and displayed until 31/05/2007
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

4.2    Second paragraph: 'The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients.'

Fifth paragraph: Fourth sentence - ' In this situation, ......etc..  (ending with) ....Severe asthma exacerbations should be managed in the usual way.

4.4  Last paragraph: 'Concomitant treatment ......etc  (ending with) ....(see section 4.5)'

4.5 Second paragraph:  'In a drug-drug interaction study.............etc  (ending with) ...risk of systemic side effects of corticosteroids.'

5.1 Last paragraph: 'In a 12-week study of 680 severe asthmatics .........................(ending with) day of ciclesonide respectively'.

5.3 Third paragraph: ' A treatment-related effect.......etc (ending with) to humans is unknown'.

10  Date of revision of the text - January 2007

 

Active Ingredients/Generics

 
  ciclesonide