Ministry of Health,
Medsafe

Dear Mr James,

REF - H201803736

Thank you for your reply to my request for information under the OIA, made on the 8th May 2018. In response to your reply, on the 14th June 2018, I have have a few questions that I would like answered as part of the request under the OIA.

Could you please send me copies of the documents Mylan supplied showing that Enlafax XR is bioequivalent to Effexor XR.

You also refer to the the fact that Enlafax has been approved for supply in the USA, Canada, UK, France and Australia but I can find no reference to Enlafax being available in any of those countries except Australia. Is Enlafax sold under a different brand name by Mylan in these countries, and if so could you please inform me what they are.

I would also like to query what knowledge you have surrounding the reports of adverse effects caused to patients by Enlafax in Australia.

Yours faithfully,

Trudi Webber