EMA: 7 product-specific guidances adopted [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2015-07-07 16:10 (3187 d 00:01 ago) – Posting: # 15048
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Dear all,

today the EMA published a new batch of product specific guidances (capecitabine, sirolimus, sorafenib, sunitinib, tadalafil, telithro­mycin, and vori­con­azole). The guidances were adopted by the CHMP on 21 May 2015 and will come into effect on 1 December 2015.
The “Compilation of individual product-specific guidance on demonstration of bio­equi­va­lence” Rev. 2 gives in its new Annex C as the effective date 1 November 2015. Lacking QA?

Links to all documents here.

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