Forxiga

RSS

dapagliflozin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Forxiga. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Forxiga.

This EPAR was last updated on 06/12/2017

Authorisation details

Product details
Name
Forxiga
Agency product number
EMEA/H/C/002322
Active substance
dapagliflozin propanediol monohydrate
International non-proprietary name (INN) or common name
dapagliflozin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BK01
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
12/11/2012
Contact address
151 85 Sodertalje
Sweden

Product information

12/10/2017 Forxiga - EMEA/H/C/002322 - WS/1167

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

DRUGS USED IN DIABETES

Therapeutic indication

Forxiga is indicated in adults aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control as:

  • monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance;
  • add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
1 rating