Summary of Product Characteristics
last updated on the eMC:
29/07/2009
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 29/07/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
| Date of revision of text on the SPC: 01-Feb-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In section 9 (Renewal of the Authorisation) the date has changed to "20 February 2009"
|
|
Updated on 11/03/2009 and displayed until 29/07/2009
|
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 revision of the text
|
| Date of revision of text on the SPC: 01-Feb-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
In section 4.4 (Special warnings and precautions for use) : the following text has been added "The excipient cetostearyl alcohol may on rare occasions give rise to local skin reactions (e.g. contact dermatitis) in sensitive people"
In section 4.8 (Undesirable effects) : the following text has been added "These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic in nature. Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area"
In section 10 (Date of revision of the text) : the date has changed to "February 2009"
|
|
Updated on 03/08/2004 and displayed until 11/03/2009
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 23/09/2003 and displayed until 03/08/2004
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 18/07/2001 and displayed until 23/09/2003
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 13/03/2001 and displayed until 18/07/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 15/08/2000 and displayed until 13/03/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 15/08/2000
|
Reasons for adding or updating:
|
|
|
|