Summary of Product Characteristics
last updated on the eMC:
19/07/2011
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 19/07/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 6. 6 - Instructions for use, handling and disposal
|
| Date of revision of text on the SPC: 01-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| the purpose of this variation is to update the Summary of Product Characteristics
(SmPC) of Varivax to refiect changes that have been made to the Company Core Datasheet (CCDS)
with respect to section 4.4 “Speciai warnings and precautions for use” and section 4.8 “Undesirabie
effects”, each under the subsection of “Transmission”. Additionaiiy, in section 4.8 “Undesirable
effects”, under the subsection of “Post-Marketing Surveiliance”, aplastic anemia has been added to
the Iist of adverse events;
|
|
Updated on 17/03/2011 and displayed until 19/07/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
| Date of revision of text on the SPC: 31-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Change of tip cap in section 6.5
|
|
Updated on 12/02/2009 and displayed until 17/03/2011
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 3 - Pharmaceutical form
-
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 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 6.2 - Incompatibilities
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 6 - Instructions for use, handling and disposal
|
| Date of revision of text on the SPC: 01-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| Change to section 2
Description of product updated
Change to section 3
Description of product updated
Change to section 4.1
Rewording of section,
Change to section 4.2
Introduction of 2 dose schedule, update to method of administration
Change to section 4.4
Reformatting of section.
Change to section 4.7
Reformatting of section
Change to section 4.8
Reformatting of section, addition of side effect observed following 2 dose regimen.
Change to section 5.1
Addition of data supporting 2 dose regimen.
Change to section 6.2
Additional statement concerning reconstitution with other medicinal products.
Change to section 6.4
Reformatting of section
Change to section 6.6
Rewording of section.
|
|
Updated on 04/08/2008 and displayed until 12/02/2009
|
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
|
| Date of revision of text on the SPC: 01-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.2
Addition of intramuscular route of administration.
Section 4.8
Update of information, following the addition if intramuscular route of administration - safety profile is comparable between intramuscular and subcutaneous routes of administration.
Section 5.1
Addition of information - Immunogenicity profile similar for both intramuscular and subcutaneous routes of administration.
|
|
Updated on 28/11/2007 and displayed until 04/08/2008
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 25/04/2006 and displayed until 28/11/2007
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 18/04/2006 and displayed until 25/04/2006
|
Reasons for adding or updating:
|
-
Change to section 10 (date of (partial) revision of the text
-
Change to section 6. 3 - Shelf Life
|
|
Updated on 11/04/2006 and displayed until 18/04/2006
|
Reasons for adding or updating:
|
-
Change to section 10 (date of (partial) revision of the text
-
Change to section 6. 3 - Shelf Life
|
|
Updated on 11/08/2005 and displayed until 11/04/2006
|
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 02/08/2005 and displayed until 11/08/2005
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 10 (date of (partial) revision of the text
-
Change to section 7 - Marketing Authorisation Holder
|
|
Updated on 27/04/2005 and displayed until 02/08/2005
|
Reasons for adding or updating:
|
-
Change to section 10 (date of (partial) revision of the text
-
Change to section 7 - Marketing Authorisation Holder
|
|
Updated on 29/09/2004 and displayed until 27/04/2005
|
Reasons for adding or updating:
|
|
|
|
