Summary of Product Characteristics
last updated on the eMC:
05/07/2011
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 05/07/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 5.3 - Preclinical Safety Data
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 16-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
This section has been updated from "No relevant pre-clinical safety data has been generated" to the following
"Non-clinical data from repeated dose toxicity and reproduction and development toxicity studies reveal no additional hazard other than those described elsewhere in the SPC".
|
|
Updated on 10/05/2011 and displayed until 05/07/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
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: 25-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
In section 6.3 the ‘after constitution’ shelf life has been increased from 5 weeks to 8 weeks.
In section 7 the address of the MAH, Paines and Byrne Limited, has been updated following a move to new premises. This entails the address changing from Lovett House, Lovett Road, Staines, TW18 3AZ, United Kingdom to 3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, United Kingdom.
In section 10 the last revision date of the text has been revised to correspond with this move to new premises as detailed in Section 7. This date is updated to 25th February 2011.
|
|
Updated on 02/07/2008 and displayed until 10/05/2011
|
Reasons for adding or updating:
|
-
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: 21-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| The original paragraph has been deleted and the following table inserted:
4.8 Undesirable Effects
|
System Organ Class
|
Rare
>1/10,000, <1/1000
|
Very rare
<1/10,000, Not known (cannot be estimated from the available data)
|
|
Immune system disorders
|
|
Hypersensitivity
|
|
Skin and subcutaneous tissue disorders
|
Pruritus
Erythema
Skin irritation
Skin burning sensation
Dry skin
Skin exfoliation
|
|
|
|
Updated on 05/01/2006 and displayed until 02/07/2008
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 03/09/2003 and displayed until 05/01/2006
|
Reasons for adding or updating:
|
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 30/08/2002 and displayed until 03/09/2003
|
Reasons for adding or updating:
|
-
Change to section 6. 4 - Special Precautions for Storage
-
Addition of Legal Category
|
|
Updated on 21/08/2001 and displayed until 30/08/2002
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
|
Updated on 07/08/2001 and displayed until 21/08/2001
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 12/01/2001 and displayed until 07/08/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 28/01/2000 and displayed until 12/01/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 28/01/2000
|
Reasons for adding or updating:
|
|
|
|
