Summary of Product Characteristics
last updated on the eMC:
31/08/2011
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 31/08/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 01-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 5.1 has been updated.
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Updated on 03/08/2011 and displayed until 31/08/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 Special Warnings and Precautions for Use
The final paragraph of this section i.e. one regarding other inhalation therapy has been amended.
Section 4.8 Undesirable Effects
The Respiratory, Thoracic and Mediastinal Disorders sub-heading of this section has been amended to include a figure (2) in superscript. The corresponding footnote text has also been amended.
Section 5.1 Pharmacodynamic Properties
This entire section has been amended.
Section 10 Date of Revision of the Text
The date has been updated to May 2011.
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Updated on 03/03/2011 and displayed until 03/08/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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- minor revision to section 4.4
- revision of section 4.8
- addition of information for section 4.7
- section 10 date of revision changed to February 2011
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Updated on 03/02/2011 and displayed until 03/03/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 of the SPC has been updated to revise the information relating to drying of the mouthpiece
Section 10 - Date of revision updated to July 2010
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Updated on 04/07/2007 and displayed until 03/02/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4: updated to include glucose statement
4.8: updated at MHRA request (re-ordered frequencies, vomiting included as a gastrointestinal disorder rather than footnote, tachycardia instead of increased heart rate)
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Updated on 23/08/2004 and displayed until 04/07/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 06/05/2004 and displayed until 23/08/2004
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Reasons for adding or updating:
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