Steglatro - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

ertugliflozin

Opinion

On 12 November 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Steglatro. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.

The CHMP adopted an extension to an existing indication, as follows:

Steglatro is indicated for the treatment of adults and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

• as monotherapy when 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 of therapies, effects on glycaemic control, cardiovascular events, and the populations studied, see sections 4.4, 4.5, and 5.1.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Steglatro (VR-0000335920)

Adopted Reference Number: EMADOC-1700519818-3545938

Key facts

• Name of medicine:
  Steglatro
• EMA product number:
  EMEA/H/C/004315
• Active substance:
  ertugliflozin l-pyroglutamic acid
• International non-proprietary name (INN) or common name:
  ertugliflozin
• Therapeutic area (MeSH):
  Diabetes Mellitus, Type 2
• Anatomical therapeutical chemical (ATC) code:
  A10BK04
• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.
• Date of opinion:
  12/11/2026
• Status:
  Positive