Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2015

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12/06/2015

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2015

Review of diabetes medicines called SGLT2 inhibitors

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of canagliflozin, dapagliflozin and empagliflozin, which are medicines known as SGLT2 inhibitors used to treat type 2 diabetes. The aim of the review is to evaluate the risk of diabetic ketoacidosis with these medicines. Diabetic ketoacidosis is a serious condition that usually develops in people with type 1 diabetes when insulin levels are too low.

More information is included in the table below.

Agenda

 
Agenda - PRAC draft agenda of meeting 8-11 June 2015


Start of referral procedure

SGLT2 inhibitors

Article-20 procedure: SGLT2 inhibitors

 

Review started
Referral notification
PRAC list of questions
Timetable for the procedure

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Contact point:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu