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: POM |
| 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 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 07-Jan-2010 |
| Legal Category: POM |
| 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 4.6 Pregnancy and Lactation - to change the advice on use of an applicator for administration during pregnancy.
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Updated on 20/01/2006 and displayed until 20/08/2010
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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 - Contra-indications
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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 4.9 - 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. 4 - Special Precautions for Storage
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Change to section 7 - Marketing Authorisation Holder
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Updated on 18/01/2006 and displayed until 20/01/2006
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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 - Contra-indications
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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 4.9 - 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. 4 - Special Precautions for Storage
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Change to section 7 - Marketing Authorisation Holder
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Updated on 19/09/2005 and displayed until 18/01/2006
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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 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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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 4.9 - 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 10 (date of (partial) revision of the text
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Change to section 7 - Marketing Authorisation Holder
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Updated on 13/12/2001 and displayed until 19/09/2005
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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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 13/12/2001
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 18/12/2000 and displayed until 25/07/2001
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Reasons for adding or updating:
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