Summary of Product Characteristics
last updated on the eMC:
22/03/2011
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 22/03/2011 and displayed until Current
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 16-Mar-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4
Polytar Plus contains arachis oil (peanut oil) and should not be used by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Polytar Plus.
10
16 March 2011
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Updated on 23/12/2010 and displayed until 22/03/2011
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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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| Date of revision of text on the SPC: 17-Dec-2010 |
| Legal Category: GSL |
| 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 19494/0053
Section 10 - 17 December 2010
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Updated on 21/08/2009 and displayed until 23/12/2010
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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: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7: Update to the address of the MAH
Section 10: Date updated
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Updated on 18/05/2009 and displayed until 21/08/2009
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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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| Date of revision of text on the SPC: |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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