Bioequivalence and Bioavailability Forum • 9 new just published

9 new just published [BE/BA News]

posted by Ohlbe – France, 2016-04-07 21:08 (3271 d 20:38 ago) – Posting: # 16174
Views: 13,875

Dear all,

EMA published today a batch of 9 new guidances: asenapine, entecavir, lenalidomide, prasugrel, rivaroxaban, sitagliptin, tacrolimus, ticagrelor, zonisamide. Date for coming into effect: 01 November 2016.

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Regards
Ohlbe

Complete thread:

EMA: 7 product-specific guidances adopted Helmut 2015-07-07 14:10 [BE/BA News]
- EMA: 7 product-specific guidances adopted mittyri 2015-07-08 13:55
  - capecitabine ≠ NTID; reference-scaling Helmut 2015-07-08 14:59
- Tadalafil: Similar technology and formulas as the originator luvblooms 2015-07-10 07:24
  - Tadalafil: Similar technology and formulas as the originator mmw 2015-07-17 11:38
- 9 new just publishedOhlbe 2016-04-07 19:08
- Five new drafts published Helmut 2016-08-23 15:09
  - New product specific guidance of Fidaxomicin Mahesh M 2016-08-24 05:58
- EMA: 7 product-specific guidances adopted (Capecitabine) Mauricio Sampaio 2016-12-12 19:33
  - Capecitabine: study with healthy volunteers mittyri 2016-12-14 12:39