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SITARIAN/ SITAGLIPTIN B&B/ SITAGLIPTIN/ SITAZITIN/ SITALAXIN/ SITAPRIDIN (Micro Labs Pty Ltd)

Product name
SITARIAN/ SITAGLIPTIN B&B/ SITAGLIPTIN/ SITAZITIN/ SITALAXIN/ SITAPRIDIN
Sponsor
Micro Labs Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
150 (255 working days)
Active ingredients
sitagliptin tartrate hemihydrate
Registration type
New generic medicine
Indication

SITARIAN/ SITAGLIPTIN B&B/ SITAGLIPTIN/ SITAZITIN/ SITALAXIN/ SITAPRIDIN (sitagliptin tartrate hemihydrate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:

  • monotherapy when metformin is considered inappropriate due to intolerance; or
  • in combination with other anti-hyperglycaemic agents, including insulin

    • [see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS for available data on different add-on combination therapies].

    Registration process

    First generic
    First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine