Summary of Product Characteristics
last updated on the eMC:
08/09/2011
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 08/09/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Sep-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| The shelf life of the product has been reduced from 3 years to 2 years due to an out of specification result for a batch of tablets under routine stability testing.
|
|
Updated on 06/05/2010 and displayed until 08/09/2011
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 date of revision of the text
-
Company name change or merger
-
Change to MA holder contact details
|
| Date of revision of text on the SPC: 27-Apr-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Change in Marketing Authorisation Holder name and address.
|
|
Updated on 21/01/2008 and displayed until 06/05/2010
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.9 - Overdose
-
Change to section 6.2 - Incompatibilities
|
| Date of revision of text on the SPC: 01/2008 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
To update sections 2; 4.2; 4.4; 5.4; 4.6; 4.9; 6.2 of the SPC to bring in line with other Wyeth products containing the same active ingredients
|
|
Updated on 24/07/2006 and displayed until 21/01/2008
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 07/2006 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| section 4.9 overdose amended to reflect changes for symptoms and management of all the active ingredients (aspirin/paracetamol/caffeine)
|
|
Updated on 17/03/2006 and displayed until 24/07/2006
|
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 26/08/2005 and displayed until 17/03/2006
|
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 12/01/2005 and displayed until 26/08/2005
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|