Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Segluromet   
Auth. number : EU/1/18/1265
Active substance : ertugliflozin / metformin hydrochloride
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: A10BD - Combinations of oral blood glucose lowering drugs
Chemical substance: A10BD23 - metformin and ertugliflozin
(See WHO ATC Index)
Indication: Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

• in patients not adequately controlled on their maximally tolerated dose of metformin alone

• in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes

• in patients already being treated with the combination of ertugliflozin and metformin as separate tablets.
Marketing Authorisation Holder: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/03/2018 Centralised - Authorisation EMEA/H/C/4314 (2018)1959 of 23/03/2018
26/04/2018 Centralised - Variation EMEA/H/C/4314/IB/1G
Updated with Decision(2018)5103 of 26/07/2018
30/07/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4314/T/2 (2018)5103 of 26/07/2018