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 1 -Name of the Medicinal product
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Change to section 3 - Pharmaceutical form
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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: 17-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1: Name change in line with guidelines.
Section 3: Change to - 'Powder for Oral Suspension'
Section 10: Change to date of revision following variation approval
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Updated on 14/09/2005 and displayed until 25/09/2009
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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 (partial) revision of the text
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Updated on 22/02/2005 and displayed until 14/09/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 23/04/2004 and displayed until 22/02/2005
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Reasons for adding or updating:
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Change from the BAN of the active substance to the rINN
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Updated on 29/04/2003 and displayed until 23/04/2004
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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 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/08/2001 and displayed until 29/04/2003
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 (date of (partial) revision of the text
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Updated on 10/02/2000 and displayed until 22/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 10/02/2000
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Reasons for adding or updating:
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