When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Vaginal capsule, soft.
White to off white egg shaped soft vaginal capsule containing a white to cream coloured hydrophobic mass. 6.3 Shelf life 24 months 5 years 6.4 Special precautions for storage Do not store above 25 30°C. Store in the original package to protect from light and moisture. 10 DATE OF REVISION OF THE TEXT 01 June 2010 20 January 2012
24 months 5 years
Do not store above 25 30°C. Store in the original package to protect from light and moisture. 10 DATE OF REVISION OF THE TEXT 01 June 2010 20 January 2012
01 June 2010 20 January 2012
Change to section 2 - Qualitative and quantitative composition
Addition of: Also contains ethyl parahydroxybenzoate (E125) and sodium propyl parahydroxybenzotae (E
Change to section 6.4 - Special precautions for storage
Addition of : to protect from light and moisture.
Change to section 9 - Date of renewal of authorisation
09 June 2009
Change to section 10 - Date of revision of the text
June 2010
Change to section 7 – Marketing Authorisation Holder
50 100 Holmers Farm Way
High Wycombe
Bucks
HP12 4EG
UK
Change to section 10 – Date of revision of the text
17th April 2008
Change to section 4.8 – Undesirable effects
Minor changes to the frequency of adverse events in table 1. Addition of Table 2 adverse events. Postmarketing adverse events was table 2 now table 3
Change to section 9 – Date of Renewal of Authorisation
3rd April 2008
Change to section 2 – quantitative and qualitative composition
Addition of standard statement
Change to section 4.2 – Posology and |Method of Administration
Changed for clarification
Change to section 4.4 – Special Warnings and Precautions for Use
Update warnings
Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
Update interactions
Change to section 4.6 – Pregnancy and Lactation
Update undesirable effects
Change to section 4.9 - Overdose
Update information
Change to section 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 5.3 - Preclinical Safety Data
Change to section 6.6 – Instructions for use, handling and disposal
Update headings
Update dates
Change to section 10 – Date of revision of text
2.
Update to include the statement ‘for full list of excipients…
6.6
Instructions for use, handling and disposal
Update Title of this section of the SPC.
10.
DATE OF REVISION OF THE TEXT
November 2006
Change to separate SPCs covering individual presentations
6.5
Nature and contents of container
Change to this section to remove reference to the fingerstall as it will no longer be included in the pack.
October 2006
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