Summary of Product Characteristics
last updated on the eMC:
21/07/2010
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 21/07/2010 and displayed until Current
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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 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 02-Jul-2010 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- To update section 4.3 (Contraindications) of the SPC to add hypersensitivity to cetostearyl alcohol
- To update section 4.8 (Undesirable effects) of the SPC to include blisters, oedema and peeling of skin using MedDRA terminology
- To update section 5.2 (Pharmacokinetic Properties) of the SPC to improve clarity of information
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Updated on 27/04/2007 and displayed until 21/07/2010
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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 4.1 - Therapeutic indications
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 5 - Nature and Contents of Container
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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: 04/2006 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1: Name changed to include "Dual Action"
Section 4: "Canesten is a broad spectrum antifungal. It also etc." has been deleted
Section 5.1: "It also exhibits activity against Trichomonas etc" has been added
Section 6.5: 25g and 30g have been added and "Dual Action" has been added to name
Section 10: Date changed to April 2006
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Updated on 15/09/2005 and displayed until 27/04/2007
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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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 4.8 - 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 6.2 - Incompatibilities
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 12/03/2004 and displayed until 15/09/2005
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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 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 04/12/2001 and displayed until 12/03/2004
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 (date of (partial) revision of the text
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Updated on 25/07/2001 and displayed until 04/12/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 25/07/2001 and displayed until 25/07/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 03/01/2001 and displayed until 25/07/2001
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Reasons for adding or updating:
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