EMEA-001677-PIP01-14 - paediatric investigation plan

Saxagliptin

dapagliflozin

Key facts

• Active Substance:
  • Saxagliptin
  • dapagliflozin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0322/2014
• PIP number:
  EMEA-001677-PIP01-14
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AstraZeneca AB

  Sweden ; E-mail: [e-mail] ; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/12/2014

Decision

P/0322/2014: EMA decision of 19 December 2014 on the granting of a product specific waiver for saxagliptin / dapagliflozin (EMEA-001677-PIP01-14)

AdoptedReference Number: EMA/759423/2014