Summary of Product Characteristics
last updated on the eMC:
30/03/2011
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 30/03/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.8 - Undesirable Effects
-
Change to section 6. 5 - Nature and Contents of Container
|
| Date of revision of text on the SPC: 14-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Change to sections 4.2., 4.4, 4.8., and 6.5. of the SPC. Addition of hereditary angioedema warning
|
|
Updated on 17/06/2010 and displayed until 30/03/2011
|
Reasons for adding or updating:
|
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
|
| Date of revision of text on the SPC: 31-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Change to section 8 following change of ownership approval
|
|
Updated on 15/07/2008 and displayed until 17/06/2010
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 03-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Change to MAH address
|
|
Updated on 02/11/2006 and displayed until 15/07/2008
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 7 - change of Marketing Authorisation holder
|
|
Updated on 09/06/2005 and displayed until 02/11/2006
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special Warnings and Precautions for Use
|
|
Updated on 12/12/2003 and displayed until 09/06/2005
|
Reasons for adding or updating:
|
-
SPC Retired pending re-submission
-
Change to section 4.1 - Therapeutic Indications
|
|
Updated on 24/03/2003 and displayed until 12/12/2003
|
Reasons for adding or updating:
|
-
Change to section 2 - qualitative and quantitative composition
|
|
Updated on 21/03/2003 and displayed until 24/03/2003
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
|
Updated on 31/05/2002 and displayed until 21/03/2003
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MA number
|
|