EMEA-001352-PIP01-12-M01 - paediatric investigation plan

metformin hydrochloride

Key facts

• Active substance:
  metformin hydrochloride
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0244/2014
• PIP number:
  EMEA-001352-PIP01-12-M01
• Pharmaceutical form(s):
  Effervescent tablet
• Condition(s) / indication(s):
  Treatment of polycystic ovary syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/09/2014
• Compliance check done:
  No

Decision

P/0244/2014: EMA decision of 29 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for metformin (hydrochloride) (EMEA-001352-PIP01-12-M01)

Adopted Reference Number: EMA/508731/2014