Summary of Product Characteristics
last updated on the eMC:
06/05/2010
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 06/05/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 27-Apr-2010 |
| Legal Category: P, 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 4.9 - Overdose
-
Change to section 6. 4 - Special Precautions for Storage
|
| 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; 4.9 and 6.4 of the SPC to bring in line with other Wyeth Products containing the same active ingredients.
|
|
Updated on 06/12/2007 and displayed until 21/01/2008
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 11/2007 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Increase in shelf life from 24 months to 36 months
|
|
Updated on 24/07/2006 and displayed until 06/12/2007
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 07/2006 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.9 overdose amended to reflect new amendments about symptoms and management of overdose for all active ingredients (Aspirin and Caffeine)
|
|
Updated on 29/09/2005 and displayed until 24/07/2006
|
Reasons for adding or updating:
|
-
Change to section 6. 4 - Special Precautions for Storage
|
|
Updated on 28/09/2005 and displayed until 29/09/2005
|
Reasons for adding or updating:
|
-
Change to section 6. 4 - Special Precautions for Storage
-
Pending awaiting re-submission
|
|
Updated on 26/08/2005 and displayed until 28/09/2005
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.3 - Preclinical Safety Data
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 10 (date of (partial) revision of the text
-
Pending awaiting re-submission
|
|
Updated on 07/01/2005 and displayed until 26/08/2005
|
Reasons for adding or updating:
|
-
Change to section 1 - trade name
|
|
Updated on 17/12/2004 and displayed until 07/01/2005
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
-
Pending awaiting re-submission
|
|