Summary of Product Characteristics
last updated on the eMC:
19/04/2011
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 19/04/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 06-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.1 Update to contents of the stoppers
10. 6 April 2011
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Updated on 26/05/2010 and displayed until 19/04/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 05-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4- To include statement on idiopathic thrombocytopenic purpura (ITP)
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Updated on 09/12/2008 and displayed until 26/05/2010
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 04-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - Reformatting
Section 2 - Additional information on production sites and cross-reference to section 6.1
Section 4.2 - Reformatting of headings
Section 4.4 - Reformatting of headings (deletion of 'special' before precautions)
Section 4.5 - Deletion of first paragraph re:avilability of co-administration data with other vaccines.
Section 4.6 - Lactation: minor change 'Persons' to 'They'
Section 4.8 - Minor changes clarifying parents/guardians of the vaccinee reporting any 'adverse' events instead of 'clinical' events
section 10 - new data: 4 December 2008
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Updated on 09/06/2008 and displayed until 09/12/2008
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.9 - Overdose
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 4.1 - Therapeutic indications
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Change to section 10 date of revision of the text
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 14-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 - Extension of indication to include children 9 months of age or older (Approved 26 Nov 2007)
Section 4.4 - Update to information regarding egg allergy ( Approved 22 Nov 2007)
Section 4.5 - Inclusion of information regarding coadministration with varicella vaccine and Priorix as a booster dose when previous vaccionation was with another MMR vaccine. Update to interval period if Priorix cannot be given at the same time as other live attenuated vaccines. (Approved 14 April 2008)
Section 4.8 - Reformatted and addition of new adverse events and frequencies observed (Approved 22 Nov 2007)
Section 4.9 - Inclusion of overdose information (Approved 22 Nov 2007)
Section 6.5 - Update vaccine description and colour (Approved 4 March 2008)
Section 9 - Last approved renewal date added
Section 10 - Date of last variation approval added
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Updated on 15/09/2004 and displayed until 09/06/2008
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Updated on 27/01/2004 and displayed until 15/09/2004
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Updated on 11/12/2003 and displayed until 27/01/2004
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 10/03/2003 and displayed until 11/12/2003
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 12/09/2002 and displayed until 10/03/2003
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 13/08/2002 and displayed until 12/09/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 26/09/2001 and displayed until 13/08/2002
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 21/09/2001 and displayed until 26/09/2001
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 06/08/2001 and displayed until 21/09/2001
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Transferred from eMC version 1
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Updated on 29/05/2001 and displayed until 06/08/2001
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Updated on 09/08/2000 and displayed until 29/05/2001
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Updated on 04/08/2000 and displayed until 09/08/2000
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Updated on 06/09/1999 and displayed until 04/08/2000
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