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.
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 advesre events was table 2 now table 3
Change to section 9 – Date of Renewal of Authorisation
Change to section 10 – Date of revision of the text
3rd April 2008
Change to section 1 – trade name
Addition of strength
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 6.5 – Nature and Contents of Container
Updated
Change to section 6.6 – Instructions for use, handling and disposal
Update headings
Update dates
Change to section 10 – Date of revision of text
1.
X
2.
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.
10.
DATE OF REVISION OF THE TEXT
November 2006
Change to separate SPCs covering individual presentations