Summary of Product Characteristics
last updated on the eMC:
13/04/2010
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 13/04/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 01-Apr-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In section 4.8 information about blood dyscrasias has been amended, and the frequency of undesirable effects updated.
|
|
Updated on 20/04/2009 and displayed until 13/04/2010
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
|
| Date of revision of text on the SPC: 16-Sep-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
In section 4.2, the following information has been added.
" Children should not be given Hedex tablets for more than 3 days without consulting a doctor."
|
|
Updated on 22/09/2006 and displayed until 20/04/2009
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 05/2006 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.5 - change of BAN term cholestyramine to rINN term colestyramine
Section 4.9 - change to overdose section to include the 'generic' overdose statement for Paracetamol containing products as recommended by MHRA following review of the TOXBASE database
|
|
Updated on 17/05/2005 and displayed until 22/09/2006
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
