Summary of Product Characteristics
last updated on the eMC:
20/09/2010
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 20/09/2010 and displayed until Current
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 12-Aug-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to section 4.5 Interaction with other medicinal products and other forms of interaction - To include interaction of vaginally applied clotrimazole with oral tacrolimus
Update to section 4.8 Undesirable effects - To include oedema, stinging/burning and genital peeling, rearrange according to the MedDRA system organ class and using MedDRA terminology
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Updated on 20/08/2010 and displayed until 20/09/2010
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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 4.3 - Contraindications
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 07-Jan-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to Section 4.2 Posology and method of administration
- To add the following advice: Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.
Update to Section 4.3 Contraindication - To add hypersensitivity to cetostearyl alcohol.
Update to Section 4.6 Pregnancy and Lactation - to change the advice on use of an applicator for administration during pregnancy. The advice is different for pessary and internal cream
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Updated on 28/10/2009 and displayed until 20/08/2010
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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: 03-Aug-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Licence Renewal
Section 10, Change of Date of Revision Text.
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Updated on 25/09/2006 and displayed until 28/10/2009
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Reasons for adding or updating:
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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: 09/2005 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10 changed from September 2004 to September 2005
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Updated on 25/09/2006 and displayed until 25/09/2006
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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| Date of revision of text on the SPC: 09/2005 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 9 08/12/2004 has been added
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Updated on 21/09/2006 and displayed until 25/09/2006
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Reasons for adding or updating:
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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: 09/2004 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10 changed from December 2004 to September 2004
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Updated on 29/09/2005 and displayed until 21/09/2006
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Reasons for adding or updating:
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