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 4.4 - Special warnings and precautions for Use
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
In section 4.4 - (special warnings and precautions for use), latex warning has been added
In section 10 - the date of last revision has been updated
|
|
Updated on 16/06/2010 and displayed until 27/06/2011
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.2 Persistence of the hepatitis A antibody response in children and adolescents has been updated. A new paragraph with current recommendations of the International Consensus Group on Hepatitis A Virus Immunity has been added.
Section 4.8 Subheading ‘Clinical Studies’ was added for clarity.
Section 5.1 Persistence of the hepatitis A antibody response in children and adolescents has been updated. A new paragraph regarding prediction on the persistence of HAV antibodies has been added.
Section 6.4 Editorial revision made for clarity and regulatory compliance
Section 10 – Update to date of revision
|
|
Updated on 29/04/2010 and displayed until 16/06/2010
|
Reasons for adding or updating:
|
-
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 5.1 - Pharmacodynamic Properties
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Update to section 4.5 regarding concomitant administration of VAQTA Paediatric with pneumococcal 7-valent conjugate vaccine and vaccines against varicella.
Update to section 4.8 additional safety data following administration of VAQTA.
Update to section 5.1 immunogenicity data on children who received VAQTA non-concomitantly or concomitantly with a vaccine against varicella and a pneumococcal 7-valent conjugate vaccine.
|
|
Updated on 11/01/2008 and displayed until 29/04/2010
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 17/01/2007 and displayed until 11/01/2008
|
Reasons for adding or updating:
|
-
Change to section 10 date of revision of the text
-
Improved Electronic Presentation
|
| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 10: Change to 16/10/2006
|
|
Updated on 11/11/2005 and displayed until 17/01/2007
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
|
Updated on 22/09/2005 and displayed until 11/11/2005
|
Reasons for adding or updating:
|
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 4.1 - Therapeutic Indications
-
Change to section 4.2 - Posology and Method of Administration
-
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 5.1 - Pharmacodynamic Properties
-
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 21/09/2005 and displayed until 22/09/2005
|
Reasons for adding or updating:
|
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 4.1 - Therapeutic Indications
-
Change to section 4.2 - Posology and Method of Administration
-
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 5.1 - Pharmacodynamic Properties
-
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 29/09/2004 and displayed until 21/09/2005
|
Reasons for adding or updating:
|
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 29/09/2004 and displayed until 29/09/2004
|
Reasons for adding or updating:
|
-
Change to section 10 (date of (partial) revision of the text
-
Improved Electronic Presentation
|
|
Updated on 29/09/2004 and displayed until 29/09/2004
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.8 - Undesirable Effects
-
Addition of Legal Category
|
|
Updated on 25/09/2003 and displayed until 29/09/2004
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 25/09/2002 and displayed until 25/09/2003
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 23/08/2001 and displayed until 25/09/2002
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
