Summary of Product Characteristics
last updated on the eMC:
07/09/2009
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 07/09/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 19-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| To increase shelf life to 3 years
|
|
Updated on 19/07/2006 and displayed until 07/09/2009
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 10 (date of (partial) revision of the text
|
| Date of revision of text on the SPC: 07/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 6.3 - Extension in shelf life from 18 months to 24 months.
Section 6.5 - Addition of a 10 pack.
|
|
Updated on 30/09/2005 and displayed until 19/07/2006
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
-
SPC Submitted in error
|
|