Summary of Product Characteristics
last updated on the eMC:
08/08/2011
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 08/08/2011 and displayed until Current
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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 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 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 4 - Special Precautions for Storage
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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: 18-Jan-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - name change from Carbomix to Carbomix 50g Granules for Oral Suspension
Section 2 - section completely rewritten
Section 3 - Odourless black granules added
Section 4.1 - spelling errors corrected
Section 4.2 - additional information about mixing granules with water and use with ipecac syrup
Section 4.4 - additional informaiton about use in unconscious patients and glycerol as an excipient
Section 4.8 - additional information about association with bezoar formation, aspiration and stool colour
Section 5.1 - correction of spelling error
Section 6.3 - sentence reworded
Section 6.4 - addition of Keep container tightly closed.
Section 6.5 - sentence reworded
Section 6.6 - section completed rewritten
Section 10 - revison date 18/01/2010
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Updated on 16/10/2009 and displayed until 08/08/2011
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Reasons for adding or updating:
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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: 13-Oct-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The revision date has been updated to 13-10-2009.
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Updated on 07/11/2006 and displayed until 16/10/2009
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Reasons for adding or updating:
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