Summary of Product Characteristics
last updated on the eMC:
23/02/2012
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 23/02/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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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 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 01-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The Summary of the Product Characteristics has undergone review.
Indications has been updated to include the statement that the product has a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically. It also offers preventive treatment of asthma.
Posology and Method of Administration has been updated to include:
Patients should be made aware of the prophylactic nature of therapy with inhaled beclometasone dipropionate and that it should be taken regularly everyday even when they are asymptomatic.
Special warnings and precautions now includes:
Patients should be made aware of the prophylactic nature of therapy with Easyhaler® Beclometasone 200 micrograms/dose and that they should be used regularly, even when they are asymptomatic
Additional and more detailed information is added regarding the use of steroids.
Undesirable effects - the information in this section has been tabulated
Pharmacodynamic sections has been updated.
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Updated on 01/09/2011 and displayed until 23/02/2012
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 30-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The SmPC and PL have been updated to include“Risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drugs reactions to intranasal corticosteroids”
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Updated on 29/07/2009 and displayed until 01/09/2011
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 01-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 10. Date of (partial) revision of the text
Correction of spelling/typographical errors.
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Updated on 11/02/2009 and displayed until 29/07/2009
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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SPC Retired pending re-submission
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| Date of revision of text on the SPC: 16-Feb-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The MA numbers have been updated
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Updated on 14/11/2006 and displayed until 11/02/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 11/09/2006 and displayed until 14/11/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Pending awaiting re-submission
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Pending awaiting re-submission
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Updated on 08/09/2006 and displayed until 11/09/2006
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Reasons for adding or updating:
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New SPC for new product
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Pending awaiting re-submission
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