Summary of Product Characteristics
last updated on the eMC:
21/10/2011
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 21/10/2011 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 4.4 - Special warnings and precautions for Use
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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: 18-Oct-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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2. Minor text adjustment - 'Also contains propylene glycol. For a full list of excipients, see section 6.1.' added
4.4. Minor text adjustment - 'PanOxyl 2.5 Aquagel contains propylene glycol. Propylene glycol may cause skin irritation.'added
10. New revison date
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Updated on 23/12/2010 and displayed until 21/10/2011
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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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Change to separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 20-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 19494/0057
Section 10 - 20 December 2010
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Updated on 05/01/2010 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: 22-Dec-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3 : Shelf-life of PanOxyl 2.5 Aquagel decreased to 12 months
Section 10: Date of revision or text updated.
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Updated on 09/12/2009 and displayed until 05/01/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 30-Nov-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1: Product name changed to:
PanOxyl 2.5 Aquagel 2.5%w/w Gel
PanOxyl 5 Aquagel 5%w/w Gel
PanOxyl 10 Aquagel 10%w/w Gel
Section 10: Date updated
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Updated on 25/08/2009 and displayed until 09/12/2009
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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 revision of the text
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| Date of revision of text on the SPC: 17-Aug-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7: Update of MAH address
Section 10: Date updated.
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Updated on 27/09/2005 and displayed until 25/08/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 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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