Summary of Product Characteristics
last updated on the eMC:
28/11/2011
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 28/11/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
|
| Date of revision of text on the SPC: 17-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
updated section 4.3 of the SmPCs with the soya warning as per the Excipients Guideline dated July 2003
|
|
Updated on 19/07/2010 and displayed until 28/11/2011
|
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: 10-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 7 – name of the MAH has changed to Almirall Hermal GmbH
Section 8 – PL number has changed
Section 10 – revision date has changed
|
|
Updated on 02/11/2009 and displayed until 19/07/2010
|
Reasons for adding or updating:
|
-
Change to section 10 date of revision of the text
-
Introduction of new pack/pack size
|
| Date of revision of text on the SPC: 08-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Addition of a bundle pack size of 2 x 500ml to the licence.
|
|
Updated on 26/09/2008 and displayed until 02/11/2009
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
