Canesten Combi Pessary & Cream
Last Updated on eMC 10-Nov-2015 View document | Bayer plc Contact details
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 10-Nov-2015 and displayed until Current
Reasons for adding or updating:
- Change to section 1 - Name of the medicinal product
Date of revision of text on the SPC: 21-Sep-2015
Legal Category:GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
removal of obsolete name from section 1Updated on 27-Nov-2014 and displayed until 10-Nov-2015
Reasons for adding or updating:
- Change to section 1 - Name of the medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC: 17-Nov-2014
Legal Category:GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
1 - To add a new brand name Canesten Thrush Combi Pessary & External Cream 500mg / 2% w/w pessary and cream2 - consequential name change
4.4 - consequential name change
4.8 - addition of information on Yellow Card Scheme
Updated on 03-Jan-2014 and displayed until 27-Nov-2014
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Fertility, pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC: 28-Nov-2013
Legal Category:GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
4.2 - Addition of ‘Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.’
4.3 - Removal of specific cetostearyl warning, instead only referring to excipients.
4.5 - Elaboration on interaction with immunosuppressants, now referring to sirolimus as well as tacrolimus
4.6 - Further elaboration on Fertility, Pregnancy and Lactation section, including specific advice on administration of intravenous clotrimazole and risks associated
4.7 - Further elaboration on warning on driving or operating machinery.
4.8 - Addition of side effects ‘erythema’ and ‘vaginal haemorrhage’
4.9 - Addition of ‘No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.’
5.1 - Elaboration of pharmacodynamics section
5.3 - Inclusion of non-clinical data
6.6 - Replaced section with ‘No special requirements.’
Updated on 20-Sep-2010 and displayed until 03-Jan-2014
Reasons for adding or updating:
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable Effects
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:
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
Updated on 20-Aug-2010 and displayed until 20-Sep-2010
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and Lactation
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:
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
Updated on 12-Oct-2009 and displayed until 20-Aug-2010
Reasons for adding or updating:
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 03-Aug-2007
Legal Category:GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Change to Date of Revision of the Text. No other changesUpdated on 20-Sep-2007 and displayed until 12-Oct-2009
Reasons for adding or updating:
- Change to section 6.1 - List of Excipients
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 01-Jan-2007
Legal Category:GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Updated on 18-Jan-2006 and displayed until 20-Sep-2007
Reasons for adding or updating:
- Change to section 4.2 - Posology and Method of Administration
- Change to section 4.3 - Contra-indications
- Change to section 4.4 - Special Warnings and Precautions for Use
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 6.2 - Incompatibilities
- Change to section 6. 4 - Special Precautions for Storage
- Change to section 7 - Marketing Authorisation Holder
Updated on 10-Jun-2004 and displayed until 18-Jan-2006
Reasons for adding or updating:
- Change to section 9 - Date of Renewal of Authorisation
Updated on 09-Jun-2004 and displayed until 10-Jun-2004
Reasons for adding or updating:
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
+44 (0)1635 563 393
+44 (0)1635 563 000
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