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.
2.
Addition of;
Excipients-contains Ethanol 96% 7.59 mg/g
For a full list of excipients, see 6.1
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Renewal date changed to 10 Jul 2009
10.
DATE OF REVISION OF THE TEXT
Changed to 30 October 2009
Change to section 6.3 – Shelf Life
3 years.
Change to section 10 – Date of revision of text
February 2008
The statement ‘Each gram contains 20 mg miconazole’ has been added.
The description of the product is added as White homogeneous gel having an orange taste.
A fuller description of the tube and dosing spoon is added. The spoon is shown to have ¼ and ½ spoon measures, not just the ½ spoon (2.5 ml) dose.
The date of renewal has been altered to 2004