Regarding your request, please find

Regarding your request, please find attached the current Company Core Data Sheet (CCDS) for Tenoxicam/Tilcotil of 6 March 2013 as Word-File.
This document already contains all the headings which are mentioned in the “Check list of SPC.pdf” (the sections correspond to the current requirements of the European QRD template for Labelling), so you could assign the contents of your SPC accordingly.

In general, the national labelling texts should be adapted by the country itself to this CCDS to achieve harmonization of the texts, wherever applicable; especially all safety relevant sections should be identical. As I realized that some of the sections of your current SPC do not correspond to the current CCDS (rather to an older version of the CCDS of Roche in 2010), would it be possible to adapt the contents now in the context of this request of the Officer?
Please also note the former e-mail of Nadja Kadetschka of 11 March 2013, as she has sent this version of the CCDS to check the national texts (see attachment).

I also realized that the text of the SPC which you have sent seems to be equal to the text of the artwork for the patient leaflet which has been revised by you and Olivia recently. Could you confirm that in general in Thailand the text for the patient leaflet is the same like for the SPC?