Summary of Product Characteristics
last updated on the eMC:
17/07/2008
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 17/07/2008 and displayed until Current
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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: 03-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Amendment to paragraph on 'prolonged use cefuroxime axeti'
Section 4.8 - Amendment to infections and infestations - removal of 'from prolonged use'
Section 10 - Added the date of approval
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Updated on 29/01/2008 and displayed until 17/07/2008
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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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: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.4 & 6.6: In order to reinforce and clarify the correct instructions in accordance with GDS, with consequential updates to the PIL and packaging components (carton and bottle label).
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Updated on 15/02/2007 and displayed until 29/01/2008
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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 4.4 - 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 09/05/2006 and displayed until 15/02/2007
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Reasons for adding or updating:
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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 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 27/04/06 |
| 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 31/10/2005 and displayed until 09/05/2006
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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 27/06/2003 and displayed until 31/10/2005
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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 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 10/03/2003 and displayed until 27/06/2003
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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 30/05/2002 and displayed until 10/03/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 20/08/2001 and displayed until 30/05/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 22/05/2002 and displayed until 20/08/2001
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Reasons for adding or updating:
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Updated on 15/05/2000 and displayed until 22/05/2002
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Reasons for adding or updating:
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