Summary of Product Characteristics
last updated on the eMC:
08/01/2010
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 08/01/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 01-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Pregnancy warnings have been updated and undesirable effects sections has been rewritten.
|
|
Updated on 06/09/2006 and displayed until 08/01/2010
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 (date of (partial) revision of the text
|
| Date of revision of text on the SPC: 02/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 7 – Change of office address from Galderma House, Church Lane, Kings Langley, Herts, WD4 8JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS
|
|
Updated on 15/08/2005 and displayed until 06/09/2006
|
Reasons for adding or updating:
|
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 16/07/2004 and displayed until 15/08/2005
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 16/07/2004 and displayed until 16/07/2004
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 18/09/2003 and displayed until 16/07/2004
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
|
Updated on 23/09/2002 and displayed until 18/09/2003
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 5 - Nature and Contents of Container
|
|
Updated on 15/08/2001 and displayed until 23/09/2002
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 06/09/1999 and displayed until 15/08/2001
|
Reasons for adding or updating:
|
|
|
|