Summary of Product Characteristics
last updated on the eMC:
05/10/2010
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 05/10/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change due to harmonisation of SPC
-
Introduction of new pack/pack size
|
| Date of revision of text on the SPC: 02-Sep-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Addition of a new pack size - 100 sachets. This pack size will not be marketed in UK.
Harmonisation of the SPC due to Mutual Recognition Procedure. Some sections reworded and some updated.
|
|
Updated on 12/03/2010 and displayed until 05/10/2010
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 24-Sep-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
In section 2 - include details regarding potassium and lactose excipients
In section 4.4 - include details regarding potassium and lactose excipients
section 9 - updated due to renewal approved.
|
|
Updated on 22/07/2008 and displayed until 12/03/2010
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 19-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.8 - Additional info. added;
"Isolated cases of mild reversible aphthoid ileal ulcers have been reported".
|
|
Updated on 23/12/2003 and displayed until 22/07/2008
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 15/09/2003 and displayed until 23/12/2003
|
Reasons for adding or updating:
|
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 3 - pharmaceutical form
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 15/09/2003 and displayed until 15/09/2003
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
Updated on 21/11/2001 and displayed until 15/09/2003
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
Updated on 20/08/2001 and displayed until 21/11/2001
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 17/08/2001 and displayed until 20/08/2001
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 06/09/1999 and displayed until 17/08/2001
|
Reasons for adding or updating:
|
|
|
|
