Summary of Product Characteristics
last updated on the eMC:
03/11/2009
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 03/11/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 15-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
For information it is section 4.4 of the SmPC that has been updated to add:
Not for use under tight bandages.
The hands should be washed immediately after application of the cream, unless the hands are the treated areas, in which case, they should be washed 30 minutes after application.
And to remove:
After applying Axsain Cream with the fingers, hands should be washed immediately.
|
|
Updated on 23/10/2008 and displayed until 03/11/2009
|
Reasons for adding or updating:
|
-
Change to MA holder contact details
|
| Date of revision of text on the SPC: 02-Oct-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Update MAH address from Oxford to Welwyn Garden City
|
|
Updated on 12/06/2007 and displayed until 23/10/2008
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 7 - Marketing Authorisation Holder changed from:
Zeneus Pharma Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
to:
Cephalon Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
|
|
Updated on 12/06/2007 and displayed until 12/06/2007
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 7 - Marketing Authorisation Holder changed from:
Zeneus Pharma Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
to:
Cephalon Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
|
|
Updated on 13/03/2006 and displayed until 12/06/2007
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MA number
-
Change to section 9 - Date of Renewal of Authorisation
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 15/09/2005 and displayed until 13/03/2006
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contra-indications
-
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 28/05/2004 and displayed until 15/09/2005
|
Reasons for adding or updating:
|
-
Company name change or merger
|
|
Updated on 19/11/2001 and displayed until 28/05/2004
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 19/07/2001 and displayed until 19/11/2001
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 03/10/2000 and displayed until 19/07/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/03/2000 and displayed until 03/10/2000
|
Reasons for adding or updating:
|
|
|
|
Updated on 18/01/2000 and displayed until 06/03/2000
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 18/01/2000
|
Reasons for adding or updating:
|
|
|
|