Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Forxiga   
Auth. number : EU/1/12/795
INN : dapagliflozin
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins
Chemical subgroup: A10BX - Other oral blood glucose lowering drugs
Chemical substance: A10BX09 - Dapagliflozin
(See WHO ATC Index)
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 (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Marketing Authorisation Holder: Bristol-Myers Squibb/AstraZeneca EEIG
Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
14/11/2012 Centralised - Authorisation EMEA/H/C/2322 (2012)8378 of 12/11/2012
21/03/2013 Centralised - Variation EMEA/H/C/2322/II/2/G
Updated with Decision(2014)1615 of 05/03/2014
21/03/2013 Centralised - Variation EMEA/H/C/2322/II/5
Updated with Decision(2014)1615 of 05/03/2014
25/04/2013 Centralised - Variation EMEA/H/C/2322/II/3
Updated with Decision(2014)1615 of 05/03/2014
19/09/2013 Centralised - Variation EMEA/H/C/2322/N/7
Updated with Decision(2014)1615 of 05/03/2014
25/10/2013 Centralised - Variation EMEA/H/C/2322/IA/9
Updated with Decision(2014)1615 of 05/03/2014
18/12/2013 Centralised - Variation EMEA/H/C/2322/II/8
Updated with Decision(2014)1615 of 05/03/2014
07/03/2014 Centralised - Variation (2014)1615 of 05/03/2014
22/05/2014 Centralised - Variation EMEA/H/C/2322/WS/537