Summary of Product Characteristics
last updated on the eMC:
27/06/2011
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 27/06/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
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: 17-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 7: MA Holder name and address (Wyeth Pharmaceuticals, Taplow to Pfizer Limited, Sandwich)
Section 8: MA Numbers (changed to reflect ownership by Pfizer under “PL 00057”)
Section 9: Date of First Authoisation
Section 10: Date of revision of the text
|
|
Updated on 06/05/2011 and displayed until 27/06/2011
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
|
| Date of revision of text on the SPC: 17-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.2 – the underlined text has been added:
The use of Zoton FasTab is not recommended in children as clinical data are limited (see also section 5.2). Treatment of small children below one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.”
|
|
Updated on 19/09/2007 and displayed until 06/05/2011
|
Reasons for adding or updating:
|
-
Change to section 3 - Pharmaceutical form
|
| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 3
Product description amended to include debossed number on tablets.
|
|
Updated on 08/05/2007 and displayed until 19/09/2007
|
Reasons for adding or updating:
|
-
Change due to harmonisation of SPC
|
| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| SPC update in line with Article 30 EC Decision on lansoprazole
|
|
Updated on 06/09/2006 and displayed until 08/05/2007
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 06/09/2006 and displayed until 06/09/2006
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 18/08/2005 and displayed until 06/09/2006
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic Indications
-
Change to section 4.2 - Posology and Method of Administration
|
|
Updated on 05/03/2004 and displayed until 18/08/2005
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MA number
-
Change to section 9 - Date of Renewal of Authorisation
|
|
Updated on 19/11/2003 and displayed until 05/03/2004
|
Reasons for adding or updating:
|
-
Change to section 1 - trade name
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 3 - pharmaceutical form
-
Change to section 4.8 - Undesirable Effects
|
|
Updated on 14/02/2003 and displayed until 19/11/2003
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
|
Updated on 20/09/2002 and displayed until 14/02/2003
|
Reasons for adding or updating:
|
|
|
|
