Summary of Product Characteristics
last updated on the eMC:
22/10/2007
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 22/10/2007 and displayed until Current
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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 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 08/2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Marketing authorisation holder changed from GlaxoWellcome to Beecham Group Plc, with subsequent change to marketing authorisation number in Section 8
Sections 9 and 10 updated
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Updated on 12/05/2005 and displayed until 22/10/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Improved Electronic Presentation
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Change to section 10 (date of (partial) revision of the text
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Updated on 20/10/2004 and displayed until 12/05/2005
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 10 (date of (partial) revision of the text
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Updated on 19/03/2004 and displayed until 20/10/2004
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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