Updated on 31/10/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 5.2 - Pharmacokinetic Properties
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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: 24-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.1 - reference to HSV exclusion
Section 5.2 - reference to neonate data
Section 10 - date of revision
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Updated on 12/08/2011 and displayed until 31/10/2011
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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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: 08-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3 – Further clarification of contra-indications
Section 4.4 – Precautions in immune-compromised patients
Section 10 – Updated revision of text
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Updated on 12/08/2008 and displayed until 12/08/2011
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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Change to section 4.6 - Pregnancy and Lactation
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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: 31-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.6 - Updated fertility statement
Section 5.3 - Updated fertility statement
Section 10 - Approval date
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Updated on 29/07/2008 and displayed until 12/08/2008
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Reasons for adding or updating:
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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: 18-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 - Renal and urinary disorders: Updated for renal pain
Section 10 - Updated with approval date
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Updated on 11/07/2007 and displayed until 29/07/2008
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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 4.8 - 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: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections 4.2, 4.4, 4.8 - p roduct information updated with the results of a review conducted to assess risk factors for the development of neurophychiatric events in elderly and people with renal insufficiency.
Section 4.8 - 7 new adverse events identified. Adverse events restructured into MedDRA body system and frequency categories.
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Updated on 04/12/2006 and displayed until 11/07/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 26/09/2005 and displayed until 04/12/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 26/09/2005 and displayed until 26/09/2005
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Pending awaiting re-submission
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Updated on 26/09/2005 and displayed until 26/09/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 11/07/2005 and displayed until 26/09/2005
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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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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 5.3 - Preclinical Safety Data
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Updated on 22/04/2003 and displayed until 11/07/2005
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Change to section 7 - Marketing Authorisation Holder
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Updated on 08/01/2003 and displayed until 22/04/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 19/12/2002 and displayed until 08/01/2003
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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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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Change to section 4.9 - Overdose
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Updated on 16/12/2002 and displayed until 19/12/2002
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Updated on 05/12/2002 and displayed until 16/12/2002
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 25/10/2002 and displayed until 05/12/2002
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 16/08/2001 and displayed until 25/10/2002
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Transferred from eMC version 1
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Updated on 15/05/2000 and displayed until 16/08/2001
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Updated on 06/09/1999 and displayed until 15/05/2000
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