Summary of Product Characteristics
last updated on the eMC:
08/06/2010
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 08/06/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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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 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 4.7 - Effects on Ability to Drive and Use Machines
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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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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 01-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 - Changes to nearly all sections following an Article 30 Procedure
Section 4.1 - Changes to nearly all sections following an Article 30 Procedure
Section 4.2 - Changes to nearly all sections following an Article 30 Procedure
Section 4.3 - Changes to nearly all sections following an Article 30 Procedure
Section 4.4 - Changes to nearly all sections following an Article 30 Procedure
Section 4.5 - Changes to nearly all sections following an Article 30 Procedure
Section 4.6 - Changes to nearly all sections following an Article 30 Procedure
Section 4.7 - Changes to nearly all sections following an Article 30 Procedure
Section 4.8 - Changes to nearly all sections following an Article 30 Procedure
Section 4.9 - Changes to nearly all sections following an Article 30 Procedure
Section 5.1 - Changes to nearly all sections following an Article 30 Procedure
Section 5.2 - Changes to nearly all sections following an Article 30 Procedure
Section 5.3 - Changes to nearly all sections following an Article 30 Procedure
Section 6.6 - Changes to nearly all sections following an Article 30 Procedure
Section 10 - Changes to nearly all sections following an Article 30 Procedure
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Updated on 11/07/2007 and displayed until 08/06/2010
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 11/07/2007 and displayed until 11/07/2007
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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 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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Section 4.5 - update to this section with regard to interactions with probenecid, oral contraceptives and methotrexate.
Section 10 - update date to 10 July 2007.
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Updated on 15/02/2007 and displayed until 11/07/2007
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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 4.8 - 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: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 31/03/2006 and displayed until 15/02/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 30/03/2006 and displayed until 31/03/2006
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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 (partial) revision of the text
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Updated on 04/02/2005 and displayed until 30/03/2006
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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 4.8 - Undesirable Effects
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Updated on 21/09/2004 and displayed until 04/02/2005
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Reasons for adding or updating:
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Change from the BAN of the active substance to the rINN
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Updated on 10/03/2003 and displayed until 21/09/2004
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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 26/09/2002 and displayed until 10/03/2003
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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 21/06/2002 and displayed until 26/09/2002
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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 4.6 - Pregnancy and Lactation
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Updated on 24/08/2001 and displayed until 21/06/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 17/08/2001 and displayed until 24/08/2001
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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 4.9 - Overdose
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Updated on 15/05/2001 and displayed until 17/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 15/05/2001
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Reasons for adding or updating:
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