Summary of Product Characteristics
last updated on the eMC:
04/05/2011
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 04/05/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 01-Apr-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
In section 2 the word 'ointment' has been changed to 'wax' to bring in-line with Martindale & BP monograph.
In section 4.4 (special warnings and precautions for use), the following has been added: Emulsifying wax contains cetostearyl alcohol which may cause local skin reaction (e.g. contact dermatitis).
|
|
Updated on 15/04/2011 and displayed until 04/05/2011
|
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: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
