Summary of Product Characteristics
last updated on the eMC:
23/12/2010
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 23/12/2010 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 10 date of revision of the text
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| Date of revision of text on the SPC: 17-Dec-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 -
GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
Trading as Stiefel
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
Section 8 - PL 19494/0050
Section 10 - 17 December 2010.
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Updated on 08/12/2010 and displayed until 23/12/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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: 29-Nov-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3 - Shelf changed to 18 months
Section 10 - Date of revision
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Updated on 18/12/2009 and displayed until 08/12/2010
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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 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: 05-Dec-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1: Name of product changed
Section 7: Address of MAH changed
Section 10: Date of approval updated
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Updated on 21/09/2006 and displayed until 18/12/2009
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.3 Addition of instructions 'comply with expiry date' for Acnegel 10 only
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Updated on 27/09/2005 and displayed until 21/09/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 24/08/2001 and displayed until 27/09/2005
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 24/08/2001
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Reasons for adding or updating:
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