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Pharmaceuticals - Union Register
Union Register of medicinal products for human use
|Auth. number :||EU/1/18/1267|
|Active substance :||ertugliflozin|
|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: A10BK - Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Chemical substance: A10BK04 - ertugliflozin
(See WHO ATC Index)
|Indication:||Steglatro 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:|
• as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
• in addition to other medicinal products for the treatment of diabetes.
(For study results with respect to combinations and effects on glycaemic control see sections 4.4, 4.5, and 5.1.)
|Marketing Authorisation Holder:||Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland
|EPAR and active 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.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|23/03/2018||Centralised - Authorisation||EMEA/H/C/4315||(2018)1903 of 21/03/2018|
|26/04/2018||Centralised - Variation||EMEA/H/C/4315/IB/1/G|
|Updated with Decision(2018)5789 of 28/08/2018|
|30/08/2018||Centralised - Transfer Marketing Authorisation Holder||EMEA/H/C/4315/T/2||(2018)5789 of 28/08/2018|