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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Forxiga
|
| Auth. number : | EU/1/12/795 |
| INN : | dapagliflozin |
| ATC: | A - Alimentary tract and metabolism A10 - Drugs used in diabetes A10B - Blood glucose lowering drugs, excluding insulins A10BX - Other oral blood glucose lowering drugs 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 14/11/2012 | Centralised - Authorisation | (2012)8378 of 12/11/2012 | ||||
| 21/03/2013 | Centralised - Variation | EMEA/H/C/2322/II/5 | ||||
| 21/03/2013 | Centralised - Variation | EMEA/H/C/2322/II/2/G | ||||