Summary of Product Characteristics
last updated on the eMC:
18/11/2011
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 18/11/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 16-Nov-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 2 - alignment of SPC to Excipient Guidelines ref propylene glycol
Section 4.4 - propylene glycol - addition of information re skin irritation
Section 10 - date of revision
|
|
Updated on 23/12/2010 and displayed until 18/11/2011
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
Change to section 10 date of revision of the text
|
| 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
|
| 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 19494/0077
Section 10 - 20 December 2010
|
|
Updated on 25/08/2009 and displayed until 23/12/2010
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 date of revision of the text
|
| 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
|
Section 7: Update to the address of the MAH
Section 10: Date updated
|
|
Updated on 22/09/2006 and displayed until 25/08/2009
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contra-indications
|
| 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
|
| Section 4.3 Corrected to 'known hypersensitivity to any of the ingredients'
|
|
Updated on 27/09/2005 and displayed until 22/09/2006
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 24/08/2001 and displayed until 27/09/2005
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|