Summary of Product Characteristics
last updated on the eMC:
25/09/2009
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 25/09/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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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 4.9 - Overdose
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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-2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2 –
Remove BP
Section 4.2
Formatting paragraphs
Section 4.4 –
Formatting paragraphs
Section 4.9
Formatting paragraphs
Section – 6.5
Additional sizes and container info
Section – 9
Amendments to authorisation date
Section – 10
Amendments to date
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Updated on 28/09/2006 and displayed until 25/09/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 27/09/2006 and displayed until 28/09/2006
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 03/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Change to address of MA holder
Section 10 - Change to text as above
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Updated on 21/09/2005 and displayed until 27/09/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Updated on 24/09/2003 and displayed until 21/09/2005
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 03/07/2001 and displayed until 24/09/2003
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Reasons for adding or updating:
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Updated on 02/04/2001 and displayed until 03/07/2001
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Updated on 06/09/1999 and displayed until 02/04/2001
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Reasons for adding or updating:
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