Summary of Product Characteristics
last updated on the eMC:
09/12/2010
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 09/12/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 03-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Details regarding the symptoms and treatment for overdose have been updated in section 4.9
|
|
Updated on 06/12/2010 and displayed until 09/12/2010
|
Reasons for adding or updating:
|
-
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 4.8 - Undesirable Effects
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 15-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.4: waring about use in patients with cardiovasular conditions, Sugar intolerance has been added. warning about use in elderly patients, hypothyroidism has been added. Use in patients with thyroid replacement has been added. A sepacial warning on hair loss and its use in elderly patients has been added. aspecial precaution to prevent bone loss has been added.
Section 4.5: The interaction with drugs has been arranged in order and some new interactions have been added.
Section 4.8:This section has been arranged as per SOC and new side-effects have been added.
|
|
Updated on 13/10/2010 and displayed until 06/12/2010
|
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: 08-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
a change in the name of the MA holder from "Goldshield Group PLC" to "Goldshield Group Limited" has been made.
|
|
Updated on 09/09/2010 and displayed until 13/10/2010
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
|
| Date of revision of text on the SPC: 02-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| National Bulk Type IB category C.I.3 a variation to update section 4.2 of the SmPC for inclusion of paediatric information in line with the European agreements as per MHRA letter dated 17 May 2010.
|
|
Updated on 07/09/2010 and displayed until 09/09/2010
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 02-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Updated section 4.2 of the SmPC for inclusion of paediatric information in line with the European agreements as per MHRA letter dated 17 May 2010.
|
|
Updated on 04/12/2009 and displayed until 07/09/2010
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
