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 3 - Pharmaceutical form
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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. 5 - Nature and Contents of Container
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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 3 - 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 6.5 - 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 28/08/2007 and displayed until 08/06/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3: To update this section to read:
"Augmentin 250/62 SF Suspension Dry powder 24 months
Reconstituted suspensions: 7 days"
Section 10:
To change the date from "11 January 200511 October 2005" to "20 August 2007"
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Updated on 24/11/2006 and displayed until 28/08/2007
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 11/2005 |
| 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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