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On 18 May 2017, 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 Onglyza. The marketing authorisation holder for this medicinal product is AstraZeneca AB.

The CHMP adopted a change to the existing indication to extend the use of Onglyza in combination with other diabetes medicines. The indication will read as follows:

'Onglyza is indicated in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

  • as monotherapy when metformin is inappropriate due to intolerance or contraindications
  • in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).'

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

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Onglyza (WS/1078) (English only) 2017-05-19  

Key facts

Product details for Onglyza
INN or common name


Therapeutic area Diabetes Mellitus, Type 2
Active substance


Date opinion adopted18/05/2017
Company name

AstraZeneca AB

Application typePost authorisation